Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

The Maintenance Technician (production, utilities, facilities) works as a key member of a high-performance team responsible for supporting daily manufacturing, utilities, and inspection & packaging operations in a pharmaceutical production environment. This position is 100% onsite at the Bloomington, Indiana facilities.

Responsibilities:

• Routine and non-routine checks and electrical/mechanical repair of production, utilities, and packaging & inspection equipment failures
• Troubleshoot and preventive maintenance
• Identify and implement continuous improvement projects
• Develop, monitor, and perform preventative maintenance procedures
• Review and track equipment component failures and help make recommendations for increased long-term reliability
• Maintain appropriate equipment documentation and change control according to internal procedures
• Participate in spare part analysis and inventory development
• Installation and startup of new equipment

Required qualifications:

• Must have a high school diploma or GED (Technical Associates degree preferred)
• 2-5 years industrial maintenance experience (or equivalent) in a multi craft environment - MAINTENANCE TECHNICIAN
• 5-8 years industrial maintenance experience (or equivalent) in a multi craft environment - SR. MAINTENANCE TECHNICIAN
• 8+ years industrial maintenance experience (or equivalent) in a multi craft environment and leadership/supervisory experience - LEAD MAINTENANCE TECHNICIAN
• Preferred experience in aseptic manufacturing environment
• Preferred HVAC/welding certification
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)

Physical / Safety Requirements:

• Must be able to lift, push/pull, and carry up to 50 pounds
• May be required to stand for over 4 hours per day
• Must be able to lift 20 pounds overhead
• Must be able to wear personal protective as required.
• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment and hand tools is required
• Must be able to gown qualify for Grade A/B areas, as needed.

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  •  Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

We are looking for Automation Engineers (level depends on experience) that are responsible for leading the identification, implementation, optimization, and maintenance of process automation and controls systems in pharmaceutical processing, packaging, and facilities. These engineers ensure efficient, quality, functional, and compliant process automation systems and supports engineering systems, capital projects, technical services, and plant support, as applicable. These positions are 100% onsite at the Bloomington, Indiana facility and reports directly to the Sr. Manager, Automation Engineering.

The responsibilities:

• Lead various aspects of support needed in the design, development, and implementation of the site process automation and controls systems
• Develop, modify, and troubleshoot PLC & HMI programs
• Specify and configure ins
• Identify and drive improvement opportunities for equipment, instrument, and process optimization, efficiency, and cost reduction through automation technologies and lead initiatives to implement projects
• Lead the deployment of the full system lifecycle for process automation and control systems including the design, assessment, selection, commissioning, validation, and implementation of systems
• Troubleshoot automation and controls systems issues, conduct root causes analysis, and implement corrective actions to minimize downtime and ensure continuous operations
• Conduct risk assessments of automation and controls systems
• Ensure automation and controls systems meet regulatory requirements by conducting and assisting with validation activities

Required qualifications:

• BS in Engineering (Computer, Electrical, Computer Science, Systems Engineering and Design, or related field), plus 2+ years of relevant experience; or HS diploma/GED and 10+ years of relevant experience
• Work experience in process automation and controls systems (including programming PLCs, SCADA, and HMI systems) in pharmaceutical and/or manufacturing environments
• Experience in reading and interpreting electrical schematics and Process & Instrumentation Diagrams (P&IDs)
• Experience in Ignition SCADA/HMI
• Knowledge of coding in Rockwell and Siemens (PLCs and HMIs)
• Knowledge of automation and controls hardware and software systems
• Ability to prioritize projects and workload
• Excellent verbal communication and technical writing skills

Physical/safety requirements:

• Duties may require overtime work, including nights and weekends
• Position requires sitting for long hours, but may also involve walking or standing for long periods of time
• Variable travel of 0-10% could be expected
• Must be able to lift, push, pull, and carry up to 50 lbs
• Must be able to lift 20 lbs overhead
• Must be able to wear personal protective equipment (PPE), as required

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

We are looking for a Process Engineer (level depends on experience) that is responsible for developing, implementing, and optimizing manufacturing packaging processes to improve efficiency, quality, and productivity. This engineer will work closely with cross-functional teams to identify areas for process improvement, troubleshoot issues, and ensure compliance with safety and regulatory standards in the pharmaceutical aseptic manufacturing or automated inspection & packaging areas. This position is 100% onsite at the Bloomington facility and reports directly to the Sr. Manager, Engineering & Maintenance.

The responsibilities:

• Demonstrates a strong ownership for the equipment and processes in the filling or packaging areas
• Implement process improvement projects that enhance efficiency, improve quality, and reduce costs for aseptic filling processes, lyophilization, or inspection & packaging processes
• Develop user requirements (URS), technical specification and design specifications for new processing (aseptic filling, lyophilization, equipment preparation, formulation) and/or automated inspection & packaging equipment and/or upgrades to existing equipment
• Author and execute protocols to include commissioning, qualification, and validation activities (FAT, SAT, IQ and OQ) for packaging systems
• Collaborates with external engineering firms or OEM in feasibility assessments, concept design, basic design, and detail design
• Develop and maintain project schedules using MS Project
• Collaborate with suppliers to source processing and/or packaging equipment parts to ensure quality standards are met
• Provide technical support and training to operations and maintenance on aseptic processing equipment or inspection & packaging equipment
• Interact with all functions and levels of management, ensuring effective, ongoing communication across teams and internal/external stakeholders
• Support with complex site investigation of key safety and production issues and events and work on the identification and implementation of CAPA (Corrective and Preventive Action) plans to address such events and prevent recurrence

Required qualifications:

• BS degree in Engineering (Chemical, Mechanical, Electrical, Packaging, Pharmaceutical, Biomedical), or a related technical field
• 1+ years of experience in aseptic processes or inspection & packaging engineering in the pharmaceutical industry (level hired for depends on years of experience)
• 0-2 years of experience (Level I)
• 2-5 years of experience (Level II)
• 5-8 years of experience (Level III/Sr.)
• 8+ years of experience (Level IV/Principal)
• Knowledge of the basic principles in aseptic processing and/or packaging engineering best practices
• Must be able to lead and execute engineering projects
• Strong understanding of packaging materials, processing, and testing methods
• Experience with PLC, HMI, Vision Systems and Building Management systems
• Strong oral and written communication skills
• Must be able to read mechanical, electrical, and P&ID drawings
• AutoCAD or equivalent component design knowledge
• Advanced proficiency in Microsoft Office Suite (Word, Excel, and Outlook)
• Experience and the ability to use enterprise software (examples include: JDE, Microsoft Dynamics, BPLM, Veeva, Trackwise, etc.)

 Physical / safety requirements:

• Duties may require overtime work, including nights and weekends
• Position requires sitting for long hours, but may also involve walking or standing for long periods of time
• Variable travel of 0-10% could be expected
• Must be able to lift, push, pull, and carry up to 50 lbs
• Must be able to lift 20 lbs overhead
• Must be able to wear personal protective equipment (PPE), as required

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

The Senior Quality Auditor is a member of the Quality Assurance Team reporting directly to the Sr Manager, Quality Auditing. They conduct internal audits ensuring compliance with all applicable cGMP regulations, processes, systems and provisions of the Quality System. They host and manage regulatory authority and client inspections. They serve as a technical expert within the Quality Auditing department. They are responsible for results in terms of quality system conformance to regulations and Simtra quality policies.

The responsibilities:

 Performs internal audits / assessments by collecting and analyzing objective evidence regarding issues and risks. Ensures that audit schedules are produced and communicated in a timely fashion. Plans, schedules, coordinates, supports, and leads detailed audits of facility practices to ensure that policies and procedures comply with worldwide regulatory agencies and Corporate Quality Policy guidelines. This includes review of updated GMP regulations and current FDA and outside of US requirements and incorporation into internal programs, where appropriate.

• Leads/supports Client audits of the facility. Prepares for the audit/assessment activity by researching background information, including previous audit results. Assists in reviewing audit responses. Maintains the assessment file through the process to closure.
• Supports routine GMP and Pre-Approval Inspection regulatory audits. Prepares for audits by coordinating documentation, arranging facility tours, reserving conference rooms, and communicating with facility subject matter experts. Assists in pre- and post- audit communications with Global Quality and regulatory bodies. Interfaces with regulatory inspectors during audits.
• Evaluates corrective and preventive action responses to assessment findings for adequacy, including root cause and timeliness.
• Conducting and confirming follow-up actions on Corporate, Client, Regulatory and Internal site compliance audits. Reports extended corrective actions to management.
• Performs procedure gap assessments to ensure compliance with Global Quality procedures.
• Maintains and makes recommendations for improvement to Quality procedures.
• Performs desktop evaluations of site’s suppliers per Global Quality procedures.
• Considered a Subject Matter Expert for department.
• Mentors other auditors.
• Trains subject matter experts for inspection readiness.

Qualifications:

• Bachelors degree required.  Preferably in a science or technical discipline.
• Minimum 5 years experience in the pharmaceutical industry, which should include at least 3 years of auditing experience.
• ASQ and/or RAB auditor accreditation is strongly desired.
• Extensive working knowledge of applicable quality and regulatory standards and regulations.
• Excellent communication skills – both written and oral.
• Work effectively independently and in team environment.
• Must demonstrate sound judgment and analytical skills to enable assessment of risk.
• Expertise in GMP regulations.
• Ability to demonstrate strong organizational skills.
• Good working knowledge of Windows based applications.
• Resourceful, self-reliant, self-motivated and confident.
• Working knowledge of quality software system (e.g. TrackWise, Veeva).
• General knowledge of Lean Six Sigma and other continuous improvement tools.

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

The role:

The Senior Maintenance Technician - Packaging works as a key member of a high-performance team responsible for supporting daily packaging operations and equipment in a pharmaceutical production environment.  This position reports to the Automation Supervisor.

.
The responsibilities:

• Routine and non-routine checks and electrical/mechanical repair of packaging equipment failures
• Troubleshoot and preventive maintenance of packaging equipment
• Identify and implement continuous improvement projects
• Develop, monitor, and perform preventative maintenance procedures
• Review and track equipment component failures and help make recommendations for increased long-term reliability
• Maintain appropriate equipment documentation and change control according to internal procedures
• Participate in spare part analysis and inventory development
• Installation and startup of new equipment

What you'll need:

• Must have a high school diploma or GED (Technical Associates degree preferred)
• 5+ years industrial maintenance experience (or equivalent) in a multi craft environment
• Preferred experience in aseptic manufacturing environment
• Preferred HVAC/welding certification
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)

Physical / Safety Requirements:

• Must be able to lift, push/pull, and carry up to 50 pounds
• May be required to stand for over 4 hours per day
• Must be able to lift 20 pounds overhead
• Must be able to wear personal protective as required.
• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment and hand tools is required
• Must be able to gown qualify for Grade A/B areas, as needed.

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
• Additional Benefits
  • Short and Long-Term Disability Insurance 
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

The Manufacturing Technical Services Representative is a member of the core client team and interacts directly with clients. The Manufacturing Technical Services Representative is responsible for technical and process improvement aspects of the project. This position is 100% onsite at the Bloomington facility and reports to the Manager, Manufacturing Technical Services.

The responsibilities:

• Owner and technical expert of commercial master batch records (MBR) for assigned projects - author, maintain and revise MBRs
• Review and release commercial batch records to production for execution
• Train manufacturing personnel on new and/or significant changes to MBRs
• Investigate Non-Conformance Report (NCR) and determine root cause to assign/own the corrective action(s)
• Authors technical studies in support of investigations or process improvements
• Own change controls and associated tasks
• Approve project related Bill of Materials
• Commercial contact for assigned internal and external clients
• Manages client project updates and reviews with all levels of management
• Participate (with assistance) in Business Review Meetings
• Partner with Program Management, Quality Assurance Associates, Quality Control Representative, and Manufacturing Representative to coordinate projects, provide support, align facility representation, and provide consistent quality information
• Participate on client calls and on-site visits to discuss projects and issue resolutions
• Participate (with assistance) in regulatory, client and internal audits as a product/process Subject Matter Expert (SME) and own the responses for observations
• Evaluates non-conformance situations for product impact and responsible for advising if product meets release criteria
• Use knowledge of manufacturing systems and equipment to write batch record and perform other duties
• Understands the Quality Agreement, Master Batch Record (MBR), Quality Control Master Document (QCMD), Regulatory and Procedural requirements that govern the client/company relationship and product

Required qualifications:

• BS degree, preferably in a science-related field
• Familiar with quality operating procedures, quality and regulatory requirements pertinent to pharmaceutical, biological and biochemical quality
• Strong communication skills, both written and verbal, with the ability to interact with many functions and levels across the organization
• Strong organizational skills, attention to detail, and collaboration skills with the ability to meet tight deadlines and manage multiple projects concurrently
• Intermediate proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook)
• Ability to use enterprise software (i.e., JDE, Trackwise, etc.)
• Ability to qualify for Grade C areas

Physical / safety requirements:

• Duties may require overtime work, including nights and weekends
• Position may require sitting or standing for long periods of time
• Ability to qualify for Grade C areas

In return, you’ll be eligible for [1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

As an Aseptic Equipment Lead (AEL), you’ll be at the heart of our sterile manufacturing operations. You’ll own the setup, performance, and optimization of a key aseptic filling line during your shift—making a direct impact on production success, product quality, and team efficiency. Working closely with Engineering, Maintenance, and Filling Operators, you’ll be the go‑to expert for the equipment in your area and a driving force behind continuous improvement.

 Schedule: 10:00pm-8:30am, Mon-Thurs

The responsibilities:

• Become the subject‑matter expert for your assigned filling line—whether syringe or vial equipment—and its supporting systems such as component washers, depyrogenation tunnels, filling and stoppering machines, cappers, tray loaders, and lyophilizer loading/unloading systems.
• Lead troubleshooting efforts by investigating complex issues, identifying root causes, and implementing effective, long‑term solutions.
• Monitor and evaluate line performance to support Out of Control Limit Reports (OCRs) and ensure inspection readiness.
• Analyze trends to uncover opportunities to reduce downtime, improve operator efficiency, and boost product yield.
• Standardize and train others on equipment setup and basic troubleshooting, ensuring operators and production leaders feel confident and capable.
• Partner with Line Engineers and Operational Excellence teams to champion improvements that enhance safety, quality, efficiency, and overall team performance.
• Maintain Grade A/B aseptic gowning certification and successfully complete operator qualification/media fill requirements.

The work environment:

You’ll work in a fast‑paced, hands‑on sterile manufacturing environment with direct interaction with complex automated equipment. Time is spent within Grade A–D cleanroom spaces, supporting the critical production of high‑quality sterile products.

Required qualifications:

• High school diploma or GED.
• At least 3 years of manufacturing experience.
• Proficiency in Microsoft Word, Excel, and Outlook, plus the ability to learn enterprise systems such as Veeva, D365, and Blue Mountain.
• Strong mechanical aptitude and the ability to troubleshoot in a hands‑on, equipment‑focused environment.

Physical / safety requirements:

• Ability to lift up to 50 lbs.
• Ability to stand and/or walk for extended periods.
• Work in Grade A–D controlled environments for long durations.
• Frequent use of hands and fingers for precise equipment manipulation.

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

The Sr. Manager of Engineering & Maintenance (E&M) leads a team of Process Engineers, Maintenance personnel and Equipment Coordinators to support all aspects of secondary packaging for parenteral pharmaceutical products. This position is part of a cell-based building management structure, complimented by peer leaders from Operations, Quality, and Technical Services departments. The incumbent will be responsible for leading a department with foundational expectations centered on safety, quality, execution, collaboration, and process improvement to support cell operational metrics and overall plant goals & objectives. The position reports to the Associate Director Engineering & Maintenance Operations.

The responsibilities:

• Responsible for maintaining departmental headcount and all associated administrative and planning functions, including interviewing candidates, hiring, onboarding & training, personnel development, performance management, scheduling, directing day-to-day activities and project oversight
• Responsible for equipment performance, preventive/scheduled maintenance, emergency maintenance, vendor scheduling, and project management - including timely repair and sourcing of critical parts or components
• Responsible for coordinating all activities and/or repairs related to facilities maintenance for building
• Responsible for Total Productive Maintenance (TPM) program focused on identifying overall equipment efficiencies to enhance production processes and quality
• Supports identification and procurement activities related to new process equipment. Includes generation of user specification documents, installation, commissioning, and qualification activities Provides oversight and management for process engineers regarding project ownership, including collaboration with CAPEX project engineers, and project timelines
• Works closely with peer cell leaders towards common goals to track and report department specific metrics within the cell
• Responsible for identification and implementation of corrective actions to improve performance and compliance
• Complies with Standard Operating Procedures (SOPs), Current Good Manufacturing Practices (cGMP), and rigorous quality standards and holds team to same expectation
• Maintains a clean and safe work area using 6S (6 Sigma) principles
• Ensures team is compliant with safe work practices and electrical requirements, including LOTO (Lock Out, Tag Out), safe work permits, and all Personal Protective Equipment (PPE) required to safely complete assigned work
• Lead and/or support a variety of complex issues & projects as applicable
• Apply technical expertise and troubleshooting philosophies with a variety of technologies including: syringe & vial aseptic filling machines and related process equipment, autoclaves, lyophilizers, terminal sterilizers, isolator systems, Human Machine Interface (HMI), PLCs, clean utilities, HVAC, SCADA systems and electrical control systems
• Ability to troubleshoot complex automated machinery and manual/mechanical based equipment or applications
• Fully accountable for the performance of self and team

Required qualifications:

• BS degree in Engineering or a related field of study
• 7+ years of manufacturing experience
• Prior experience and familiarity working in a cGMP environment
• 3+ years of leadership / supervisory experience 
• Demonstrated examples of successful project execution
• Track record in technical management of process equipment in a manufacturing environment, with experience in electrical, mechanical, and automated applications
• Able to analyze and solve complex problems
• Knowledge of GMPs, FDA guidelines, purchasing practices and process validation
• Team building experience in guiding multi-disciplinary teams on medium complexity issues, while providing technical direction to individual engineering disciplines
• Ability to translate business goals into action plans
• Understanding and proficiency in reliability-centered maintenance principles and practice
• Results-oriented mindset, capable of independent thought, adaptable, ready to respond and react to real-time situations with realistic and viable technical, organizational, and administrative solutions
• Advanced proficiency in Microsoft Office Suite
• Ability to utilize enterprise software applications: Maximo, Veeva, Microsoft Dynamics, Blue Mountain
• Ability to communicate effectively and professionally
• Ability to write and review technical documents
• Demonstrated efficient written and verbal communication skills
• Minimal travel required (less than 10%), including potentially supporting equipment FAT
• Ability to apply and utilize Root Cause Analysis (RCA) tools

Physical / safety requirements:

• Ability to stand or sit for extended periods of time
• Ability to utilize required personal protective equipment (PPE)
• Dexterity and physical condition to perform some level of repetitive motion tasks

In return, you’ll be eligible for [1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy: https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

The Microbiology Technician is an entry-level position in the Microbiology lab.  This position works independently to perform routine sampling and process samples in support of the Microbiology department. This position reports to a Microbiology Supervisor.

The responsibilities:

• Samples controlled environments per the sampling Master Plan utilizing aseptic technique.
• Documents and processes samples in a Laboratory environment.
• Performs real time risk assessments of the manufacturing areas and process.
• Accurately distinguishes and counts microbial recoveries (mold and bacteria)
• Enters data into Laboratory Information Management System.
• Maintains data integrity and ensures compliance with company standard operating procedures (SOP’s) and worldwide regulatory requirements
• Will be required to recognize non-conformances.

Desired qualifications:

• High school diploma or GED.
• Prior experience preferred.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include:  JDE, BPLM, Pilgrim, Trackwise, LIMS etc.)
• Must be able to communicate well. 

Physical / Safety Requirements:       

• Must be able to gown qualify for Grade A/B area.
• The position sometimes requires extended periods of standing.
• Must be able to wear applicable Personal Protective Equipment.
• Duties may require overtime work, including nights, holidays, and weekends
• Use of hands and fingers to manipulate office and laboratory equipment is required
• Must be able to lift 20 lbs
• Must be able to qualify for 20/25 corrected vision and pass color blindness test.

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

The Validation Lead/Associate III, Commissioning Qualification, Validation is a strong individual contributor within the Validation and Qualification Department. This position oversees and executes equipment FAT, SAT, IQ, OQ, PQ activities along with validation and documentation activities. In addition, it includes contribution roles within Sterility Assurance and Cleaning Validation. This position reports to the Sr. Manager, Technical Services.

Responsibilities:

• Provide guidance, support, direction, and leadership through positive interaction with all personnel during daily operations.
• Represents CQV in internal, client, and regulatory audits as needed.
• Develops procedures and supports the facility equipment qualification and validation program.
• Conducts or coordinates performance qualification execution for new products.
• Maintain and generate accurate and complete records, reports and documentation as required for summary preparation.
• Makes process improvements and modifications to the validation program as needed.
• Initiates and drives change controls (CCM).
• Review and approve Master Batch Records, Master Specification Sheets, Line Manufacturing Records and Bill of Materials.
• Author and approve qualification and validation documents
• Attend Equipment FAT, including international travel as required.
• Leads and participates in planned maintenance activities, including HEPA certification and visual airflow testing (smoke testing).

 Requirements (Education and Experience):

• Bachelor’s degree required, preferably in a science or technical area
• Minimum of 2 years related experience required, preferably 2 years supervisory experience.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)
• Self-directed with high initiative and ownership
• Critical thinking, creative thinking, and problem solving skills

Physical / Safety Requirements:

• Ability to meet Grade C and D gowning requirements.
• Duties will require overtime work, including nights and weekends.
• Use of hands and fingers to manipulate equipment is required.
• Position requires standing for long hours, but may involve walking or sitting for periods of time.

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

The Filling Group Leader is a member of the Manufacturing Leadership Team reporting directly to the Manufacturing Supervisor.  They provide direct support to manufacturing to ensure that finished products meet the required specifications by coordinating activities of Filling Operators who perform in the manufacturing areas.  The Filling Group Leader provides decision-making and oversight to ensure compliance to all regulatory agency regulations and guidelines and to Simtra Standard Operating Procedures.  This position fully supports and drives quality operations on the production floor and communicates effectively with production team members, multiple levels of management, and other customer support departments.  The Filling Group Leader creates an environment where teamwork, productivity, safety, identity, strength, purity, and quality (SISPQ) are reflected in the finished product. 

This position is required to work all designated plant holidays.

First Shift - 6AM-4:30PM (Monday-Thursday)

The responsibilities:

• Delegate, coordinate, and schedule activities of assigned team members.
• Recommend measures to improve performance and increase efficiency
• Train and mentor other team members.
• Troubleshoot process problems and respond to process alarms.
• Participate on Continuous Improvement teams.
• Assist in developing/reviewing batch records of new and existing projects.
• Assist in establishing and orienting new projects for production
• Review project plans and batch records prior to operations; monitor assigned team’s documentation in logbooks and batch records.  
• Organize and coordinate general cleaning and sanitizations throughout all filling suites.
• Identify potential causes and verify/eliminate each one to determine the true root cause behavior
• Required to maintain attendance in accordance with the Bloomington Attendance Policy
• Scheduled weekend overtime will be required

The work environment:

Classified pharmaceutical environment wearing required gowning. Must be able to work safely with materials required to produce pharmaceutical products, including chemicals, compounds, glassware and sanitization solutions.  Must be able to occasionally (1-33% of the time) work in a confined/clustered work space.  

Desirable qualifications:

To perform this job successfully an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals to perform the essential functions: 

• Ability to work independently
• Good communication skills
• Good documentation skills, including legible handwriting
• Good interpersonal skills
• Basic computer skills
• Basic math skills
• Knowledge of aseptic manufacturing practices
• Knowledge of standard operating procedures, specifications, and job-specific training materials/Subject Matter Expert
• Requires the operations of multiple types of equipment related to the manufacturing operations as well as hand operated equipment including, but not limited to, such things as calipers, scales, gauges, and other measuring devices

Physical / safety requirements:

• Occasional (1-33%)
• Sitting, climbing stairs and ladders, balancing, kneeling, operating controls
• Lifting and carrying up to 70 lbs
• Pushing and pulling up to 35 lbs
• Frequent (34-66%)
• Standing, walking, reaching forward and overhead, stooping, crouching, 
• Lifting and carrying up to 37 lbs
• Constant (67-100%)
• Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping

Additional requirement(s):

• High school diploma or GED required
• 6 months of previous Pharmaceutical or Manufacturing experience preferred.
• Final candidates for Group Leader will be required to pass a post offer/pre-employment job placement examination which will test the physical capabilities to perform the essential functions of the job.

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.                                                                                                                                          

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Privacy Policy:
Privacy Policy — Simtra BioPharma Solution

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

We are seeking a reliable, detail‑oriented Warehouse Coordinator to support receiving, shipping, storage, inventory accuracy, and picking operations across our supply chain. This position plays a key role in ensuring safe, compliant, and efficient material movement—from raw material receipt to final product shipment.

Assignments may vary based on warehouse area (Raw Materials, Finished Product, Production Support). Some travel between facilities and occasional overtime are required.

The responsibilities:

Shipping & Receiving

• Safely load and unload trucks; verify BOL/packslip accuracy and assess for damages.
• Properly pack materials for shipment, including use of FedEx/UPS systems.
• Complete accurate documentation for shipping, receiving, and batch dispensing activities.
• Investigate and adjust orders for shortages or damages as needed.
• Follow all applicable regulations including DOT, IATA, and internal SOPs.
• Maintain compliance for shipping, receiving, storage, and transport of materials including hazardous goods.

Warehouse Operations

• Perform cycle counts, temperature monitoring, work order picking, ERP transactions, and material storage.
• Maintain inventory accuracy and monitor workflow throughout the shift.
• Operate PIT (powered industrial trucks) and other warehouse equipment safely and efficiently.
• Respond to environmental chamber alarms.
• Support internal and external operational demands across multiple sites.

Truck Driving & Material Transport

(Must obtain For‑Hire license within 45 days of start date)

• Drive company trucks to move materials between warehouses and facilities at correct temperature conditions.
• Complete daily vehicle inspections, cleaning, fueling, and temperature control checks.
• Prepare dangerous goods documentation (BOLs) when required.
• Download and maintain truck data logs.
• Dispense materials from the Raw Materials warehouse.
• Use barcode scanning equipment for all transactions.

Required qualifications:

• High school diploma or GED required; Associate degree preferred.
• Minimum 1 year of warehouse or technical office experience.
• Ability to operate forklifts and material handling equipment.
• Ability to obtain Hazardous Materials certification.
• Proficiency with Microsoft Word, Excel, and Outlook.
• Ability to use enterprise systems (e.g., D365, Veeva, Trackwise).

Physical / safety requirements:

• Ability to lift up to 50 lbs.
• Able to bend, twist, stoop, and lift regularly.
• Must work overtime as required, including nights and weekends.
• Ability to sit or stand for long periods.
• Ability to operate PIT equipment for extended periods.
• Must be able to work in extremely cold environments (–65°C to –85°C).
• Manual dexterity required for handling equipment and documentation.

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Summary: 

The Formulation & Preparation Operator (Operator II & III) position supports aseptic filling operations by staging and delivering components, conducting in-process testing, weighing materials, formulation of product, and conducting in-process testing, filtration,  cleaning and sanitization, sterilization of equipment, batch reconciliation, compliant gowning, setup and operation of parts washer, autoclaves, and tank cleaning in conformance with current Good Manufacturing Practices and Good Documentation Practices (cGMP/GDP) standards.  The Operator will also initiate minor revisions to existing documents and troubleshoot simple processes / equipment failures. The Operator may be required to cross-train as a support Operator for additional areas. This position reports to the Manufacturing Supervisor. 

Shift structures:

1: M-Th 7:00 – 16:00

2: M-Th 15:00 – 00:00

3: M-Th  23:00 - 8:00

4: Fr-Su 7:00 – 19:30

5: Fr-Su 19:00 – 7:30

Essential Duties and Responsibilities (these are primary responsibilities of the role and the incumbent will perform other duties as assigned): 

• Understand and follow current Good Manufacturing Practices (GMP) 

• Understand and follow current Good Documentation Practices (GDP) 

• Perform routine cleanup, line clearances, and sanitizations as assigned by area supervision to maintain cGMP compliance within the Cleanroom work areas.  Perform sanitizations in a timely and effective manner in accordance with cGMPs and Simtra procedures, maintaining production schedule.   

• May be required to cross train as a support operator to assist additional manufacturing areas. 

• Maintain organization at all times within the classified areas to ensure equipment segregation, readiness and to prevent any contamination or rejection of batches. 

• Perform routine verification of equipment and instruments. 

• Compare Lot numbers to ensure correct components are being used for the specified batch 

• Complete calculations to support preparation and formulation activities 

• Retrieve and test in-process samples 

• Clean, Sterilize, and sample equipment 

• Setup and operate autocalves, parts washers, tank cleaning, and formulation stations in Cleanroom areas.   

• Assist in the training and development of other team members 

• Required to maintain attendance in accordance with the Bloomington Attendance Policy 

• Scheduled weekend overtime may be required  

Job Requirements (Education, Experience and Qualifications): 

• High school diploma or GED required, 6 months of previous Pharmaceutical or Manufacturing experience preferred. 

• Must be able to understand, speak, read and write English in order to comply with necessary SOP’s, job-specific training materials, GMP’s, and other manuals. 

• Basic Computer skills in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: Veeva, D365, Blue Mountain, etc.) 

• Must have the ability to work effectively in a ”hands on environment” capable of troubleshooting complex equipment and systems  

• Competency in operation of multiple types of equipment related to the manufacturing operations as well as hand operated equipment including, but not limited to, such things as calipers, scales, gauges, and other measuring devices.  Ability to demonstrate proficiency in reading equipment drawings.  Ability to work safely with equipment under pressure. 

Physical / Safety Requirements 

• Must be able to lift and carry up to 70 lbs, and push and pull up to 150 lbs. 

• Extended periods of standing and/or walking 

• Extended periods in Grade A, B, C, D production environments 

• Use of hands and fingers to manipulate equipment is required 

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements. Employees must be in their current position for a minimum of twelve (12) months and be in good standing before applying for other internal opportunities.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

The role:

The Manufacturing Manager is responsible for all production activities on a shift, supporting multiple filling lines manufacturing injectable drug products. The Manufacturing Manager leads a team of Manufacturing Supervisors and reports directly to the Senior Manufacturing Manager (Building Manager). The manager will lead, organize, and manage personnel and activities in all manufacturing activities under cGMP regulations, to serve as the primary contact for manufacturing related communications on the shift, and to provide guidance to the leadership team to ensure consistent execution and improvement of the manufacturing process. The Manufacturing Manager creates an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.

Its responsibilities:

• Lead a team of manufacturing supervisors to compliantly meet the production schedule in controlled environments.
• Partners with peers in other manufacturing buildings and on other shifts to ensure the site schedule is maintained.
• Interviews, hires, coaches, and develops staff. Provides timely and accurate feedback recognizing good / poor performance. Establishes clear direction and priorities for building leadership team, empowers team members to obtain results that support strategic objectives.
• Develop, deploy, and properly manage processes to consistently “run the business” and “improve the business”.
• Partners with quality and technical services leaders to either author, review and / or approve investigations and drive timely closure to meet client delivery dates.
• Approves SOP’s, validations, and protocols in a timely manner.
• Partners with client teams to support client projects and client audits.
• Provide technical expertise and resources, cooperating and coordinating with Quality, Program Management, Engineering, Maintenance and Technical Services.
• Ensures organization’s budget is met and maintains expenses within the plan.
• Regularly interacts with senior management and client representatives on matters concerning several functional areas, divisions, and/or customers.
• Takes personal responsibility to develop, deploy, and properly manage a culture of safety and working conditions. Adheres to all environmental, health, and safety SOPs and policies. Actions and decisions must reflect that our team member’s safety is always first on our minds.
• Leads in such a manner that inspires the trust of his / her subordinates, peers, and superiors. Must lead as a role model of respect and integrity.
• Must be a lean leader. Instills a culture of “go and see”. Engage with team members where the work is done. Embrace and adopt best practices. Setting the example is not the only thing in influencing others, it is the main thing.

Desirable qualifications:

• Bachelor’s degree strongly preferred, with emphasis on a scientific or engineering discipline.
• Minimum 5 years’ experience in all aspects of the aseptic pharmaceutical manufacturing process.
• Must have knowledge of GMPs and worldwide regulatory agency guidelines.
• Minimum 3 years in a leadership role, preferably in parenteral manufacturing.
• Lean Manufacturing experience required (i.e. value stream mapping, leading kaizen events to drive positive change on the floor, and teaching people to think)
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, MAXIMO, Trackwise, etc.)

Physical / safety requirements:

• Ability to stand for extended periods of time
• Physical coordination/flexibility to allow gowning for clean room environments
• Utilize applicable personal protective equipment, including safety shoes/toe caps, gloves, eye protection, heat resistant wear and hearing protection
• Dexterity and physical condition to perform some level of repetitive motion tasks
• Ability to wear respirator usage when product or task requires
• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Must be able to gown qualify for Grade A/B areas (filling)
• Position may require sitting for long hours

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

This position executes process validation activities that meet worldwide regulatory agency requirements, internal company standards/best practices and current industry practices. This position interacts with the client and the cross functional client team members to develop process validation strategies and creates process validation protocol and summary documents. This position reports to the Sr. Manager, Technical Services, and is 100% onsite at the Bloomington, Indiana facility.

The responsibilities:

• Supports the process validation program.
• Develops and writes process validation procedures.
• Monitors regulatory and industry validation practices to assess our compliance.
• Interacts with the client and client team to define process validation scope.
• Designs and executes the appropriate development Technical Studies to define process parameters.
• Uses statistical tools to design and analyze technical study data.
• Creates a risk assessment of the process to be validated.
• Creates process validation protocols.
• Conducts or coordinates process validation execution for new and existing products.
• Prepares validation summaries.
• Uses statistical tools to analyze process validation data.
• Performs annual reviews / continued process verification (CPV) of validation projects.
• Investigates and executes validation related Corrective and Preventive Actions.
• NCR investigation owner for process validation related, as needed
• Creates and maintains visual controls for Process Validation group
• Serves as Subject Matter Expert (SME) for process validation.
• Independently Participates in regulatory, client and internal audits and a product/process Subject Matter Expert (SME)Develop Industry knowledge, project proficiency, and be able to work independently
• Must be able to identify opportunities for optimization of processes within the department
• Proficiently uses statistical tools to design and analyze technical study data.

Desirable qualifications:

• Bachelor’s degree required, preferably in a science or engineering-related field.
• Minimum of 5 years of technical experience (validation preferred) in parenteral manufacturing.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include:  JDE, BPLM, Pilgrim, Trackwise, etc.).
• Ability to communicate effectively at all levels.
• Sound industry knowledge, project proficiency, and be able to work independently. May be considered a subject matter expert (SME) in various disciplines.
• Must be able to identify opportunities for optimization of processes within the department or the plant.
• Ability to work independently or in teams.

Physical / Safety Requirements:

• May require overtime work, including nights and weekends
• Sitting for long hours and walking/standing for long periods of time
• Must be able to gown for Grade C area

In return, you’ll be eligible for [1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • Short and Long-Term Disability Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
• Additional Benefits
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/25

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

We are seeking a reliable, detail‑oriented Warehouse Coordinator to support receiving, shipping, storage, inventory accuracy, and picking operations across our supply chain. This position plays a key role in ensuring safe, compliant, and efficient material movement—from raw material receipt to final product shipment.

Assignments may vary based on warehouse area (Raw Materials, Finished Product, Production Support). Some travel between facilities and occasional overtime are required.

The responsibilities:

Shipping & Receiving

• Safely load and unload trucks; verify BOL/packslip accuracy and assess for damages.
• Properly pack materials for shipment, including use of FedEx/UPS systems.
• Complete accurate documentation for shipping, receiving, and batch dispensing activities.
• Investigate and adjust orders for shortages or damages as needed.
• Follow all applicable regulations including DOT, IATA, and internal SOPs.
• Maintain compliance for shipping, receiving, storage, and transport of materials including hazardous goods.

Warehouse Operations

• Perform cycle counts, temperature monitoring, work order picking, ERP transactions, and material storage.
• Maintain inventory accuracy and monitor workflow throughout the shift.
• Operate PIT (powered industrial trucks) and other warehouse equipment safely and efficiently.
• Respond to environmental chamber alarms.
• Support internal and external operational demands across multiple sites.

Truck Driving & Material Transport

(Must obtain For‑Hire license within 45 days of start date)

• Drive company trucks to move materials between warehouses and facilities at correct temperature conditions.
• Complete daily vehicle inspections, cleaning, fueling, and temperature control checks.
• Prepare dangerous goods documentation (BOLs) when required.
• Download and maintain truck data logs.
• Dispense materials from the Raw Materials warehouse.
• Use barcode scanning equipment for all transactions.

Required qualifications:

• High school diploma or GED required; Associate degree preferred.
• Minimum 1 year of warehouse or technical office experience.
• Ability to operate forklifts and material handling equipment.
• Ability to obtain Hazardous Materials certification.
• Proficiency with Microsoft Word, Excel, and Outlook.
• Ability to use enterprise systems (e.g., D365, Veeva, Trackwise).

Physical / safety requirements:

• Ability to lift up to 50 lbs.
• Able to bend, twist, stoop, and lift regularly.
• Must work overtime as required, including nights and weekends.
• Ability to sit or stand for long periods.
• Ability to operate PIT equipment for extended periods.
• Must be able to work in extremely cold environments (–65°C to –85°C).
• Manual dexterity required for handling equipment and documentation.

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

The Senior Process Validation Engineer is a key member of the Technical Services organization, responsible for leading and supporting validation activities for sterile injectable manufacturing processes within a regulated pharmaceutical CDMO environment. This role focuses on process validation strategy, execution, lifecycle management, and maintaining the validated state to ensure compliant, robust, and inspection‑ready operations.

The Senior Process Validation Engineer partners closely with Manufacturing, Quality, Validation, Engineering, Tech Transfer, Supply Chain, and Regulatory teams to implement risk‑based approach that support safe, reliable, and scalable sterile drug product manufacturing. This position is full time and based onsite at the Simtra Bloomington facility.

The responsibilities:

• Provide technical and strategic leadership for process validation of new and existing sterile injectable manufacturing processes, including formulation, compounding, filtration, aseptic filling, lyophilization, and terminal sterilization, as applicable
• Own and drive lifecycle process validation strategy, ensuring risk‑based, scientifically justified approaches aligned with FDA/EMA guidance, ICH expectations, and internal quality standards
• Lead the development, review, and approval of key validation deliverables, including Process Validation Master Plans, risk assessments, protocols, control strategy elements, and final validation summary reports
• Set validation direction and standards for parameters, sampling strategies, acceptance criteria, and statistical approaches; ensure consistent application across products, programs, and manufacturing areas
• Serve as the primary validation interface with Manufacturing, Quality, Engineering, and external clients to ensure end‑to‑end process readiness for PPQ and commercial manufacturing
• Lead process validation planning and execution for technology transfers, including assessment of development history, identification of validation gaps, definition of validation scope, and readiness for PPQ execution
• Provide senior oversight and technical guidance for equipment, facility, and utility qualification activities, ensuring robust alignment with process validation requirements
• Provide expert validation impact assessments for changes related to process, equipment, raw materials, analytical methods, and facilities, supporting change control and regulatory commitments
• Establish and oversee continued process verification programs
• Act as on‑the‑floor validation lead during PPQ execution, process confirmation runs, technology transfer campaigns, and high‑risk or high‑visibility manufacturing operations
• Ensure validation documentation is inspection‑ready, supporting internal audits, client audits, and global regulatory inspections
• Serve as a SME during regulatory inspections and client audits; lead inspection preparation, participate in interviews, and support responses to inspection observations
• Continuously improve validation practices, incorporating lessons learned, regulatory trends, and industry best practices to enhance efficiency, compliance, and product quality

Required qualifications: 

• Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline
• 5–8+ years of experience in process validation, CQV, MS&T, or manufacturing support within a regulated pharmaceutical environment
• Strong understanding of sterile injectable manufacturing processes and aseptic processing principles
• Solid working knowledge of cGMP requirements and validation lifecycle concepts
• Demonstrated experience authoring and executing process validation protocols and reports

Preferred qualifications:

• Experience working in a CDMO environment and sterile injectable drug product manufacturing
• Familiarity with equipment and facility qualification and CSV validation
• Experience supporting regulatory inspections and client audits as a validation SME
• Knowledge of continued process verification, process capability analysis, and lifecycle management
• Experience working with electronic validation systems, MES, or electronic batch records

Physical / safety requirements:

• Occasional overtime may be required, including evenings or weekends to support validation execution or manufacturing schedules
• Position requires extended periods of sitting with routine walking and standing in manufacturing areas
• Must be able to qualify for classified manufacturing area gowning as applicable
• Must be able to wear required personal protective equipment (PPE)

In return, you’ll be eligible for [1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

The Sr. Manager of Aseptic Operations has responsibility for all operations occurring within their respective Aseptic Operations Cell at the Bloomington, Indiana site.  As a member of the Cell Leadership Team alongside their Quality, Engineering & Maintenance, and Technical Services Sr. Manager counterparts, the Sr. Manager of Aseptic Operations has responsibility for strategic leadership of the operations organization in their respective Aseptic Operations Cell, reporting to the Director of Aseptic Operations.  The Sr. Manager will lead, organize, and manage personnel and activities in all manufacturing activities under cGMP regulations, to serve as the primary contact for manufacturing related communications, and to provide guidance to the leadership team to ensure consistent execution and improvement of the manufacturing process. The Sr. Manager, Aseptic Operations creates an environment where teamwork, productivity, safety, identity, strength, purity, and quality (SISPQ) are reflected in the finished product.

Essential Duties and Responsibilities:

• As the Operations leader within the Cell Leadership Team, the Sr. Manager of Aseptic Operations has accountability for successful execution of the manufacturing plan to deliver on the site’s two primary KPIs:  Right First Time and On Time Delivery
• Takes personal responsibility to develop, deploy, and properly manage a culture of safety and working conditions.  Adheres to all environmental, health, and safety SOPs and policies.  Actions and decisions must reflect that our team member’s safety is always first on our minds
• Leads in such a manner that inspires the trust of his / her subordinates, peers, and superiors.  Must lead as a role model of respect and integrity
• Must be a lean leader.  Instills a culture of “go and see”. Engage with team members where the work is done. Embrace and adopt best practices.  Must believe in 6S…it is the foundation of quality and a lean enterprise. Setting the example is not the only thing in influencing others, it is the main thing
• Defines value for products/services from a customer perspective; focuses and aligns all actions of building leadership team and its team members to create value for the customer
• Interviews, hires, coaches, and develops staff. Provides timely and accurate feedback recognizing good / poor performance.  Establishes clear direction and priorities for building leadership team, empowers team members to obtain results that support strategic objectives
• Develop, deploy, and properly manage processes to consistently “run the business” and “improve the business”
• Leads / partners with Quality, Technical Services, and Engineering & Maintenance leaders to either author, review and / or approve deviations and drive timely closure to meet client delivery dates
• Approves SOP’s, validations, and protocols in a timely manner
• Partners with client teams to manage client projects and host client audits
• Provide technical expertise and resources, cooperating and coordinating with Quality, Program Management, Engineering, Maintenance and Technical Services
• Develops the organization’s annual operating budget and maintains expenses within the plan
• Regularly interacts with senior management and executive leadership team members on matters concerning performance against the business plan
• Interfaces with the other manufacturing operations management staff/customers to ensure our quality commitments are met

Job Requirements (Education and Experience):

• Bachelor’s degree required
• Minimum 8 years’ experience in all aspects of the aseptic manufacturing process preferred
• Must have knowledge of GMPs and worldwide regulatory agency guidelines
• Minimum 5 years in a leadership role
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include:  JDE, BPLM, Pilgrim, etc.)

Physical / Safety Requirements:

• Ability to stand for extended periods of time
• Physical coordination/flexibility to allow gowning for clean room environments
• Utilize applicable personal protective equipment, including safety shoes/toe caps, gloves, eye protection, heat resistant wear and hearing protection
• Dexterity and physical condition to perform some level of repetitive motion tasks
• Ability to wear respirator usage when product or task requires
• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Must be able to gown qualify for Grade A/B areas (filling)
• Position may require sitting for long hours

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

 We are seeking a proactive, safety‑minded Supply Chain Warehouse Supervisor to join our Warehousing Leadership Team. This supervisor oversees daily warehouse operations, leads a team of material coordinators and specialists, and ensures materials flow efficiently and accurately across multiple sites—including filling and complex operations, offsite raw materials warehouses, and transport between Bloomington locations.

This position plays a critical role in ensuring material availability, maintaining cGMP compliance, supporting production, and upholding inventory accuracy from receipt through final product shipment. The ideal candidate is a strong leader who thrives in a fast‑paced, regulated environment and is committed to continuous improvement.

The responsibilities:

Leadership & Team Development

• Provide daily leadership, coaching, direction, and positive support for warehouse personnel across multiple shifts.
• Interview, hire, train, and develop team members; conduct annual performance reviews.
• Set performance objectives and development plans for direct reports.
• Partner with Warehouse Group Leads to deploy staff and manage coverage, including PTO and weekend scheduling.

Warehouse Operations Management

• Oversee daily warehouse activities including scheduling, staffing, training, auditing, and compliance.
• Ensure material availability to support manufacturing schedules and production goals.
• Coordinate material movement, picking, staging, and transportation between all company sites.
• Maintain clean, organized, compliant storage areas using 6S and safety best practices.
• Support and enforce cGMP, OSHA, SOP, DOT, FMSCA, EHS, and other regulatory requirements.

Continuous Improvement & Compliance

• Lead continuous improvement initiatives using project management, capacity planning, and Kaizen problem‑solving tools.
• Ensure inventory accuracy via cycle counts, reconciliation, and ERP management.
• Support and lead investigations (NCR, SNCR), own CAPAs, and serve as a Change Control owner.
• Author and approve reports, SOP changes, and documentation as needed.
• Represent the company in audits and inspections; lead client tours.

Material Flow & Transportation

• Oversee truck driving and transport operations to ensure safe and compliant movement of WIP, FG, and RM materials.
• Ensure FIFO/FIFE staging and timely dispensing for manufacturing.
• Cross‑train and support as a warehouse specialist or driver as needed.
• Maintain equipment operations, preventive maintenance, and repair coordination.

Systems & Metrics

• Serve as SME in ERP systems to train staff, troubleshoot issues, and ensure accurate inventory transactions.
• Create, maintain, and update warehouse and supply chain performance metrics.
• Support shift‑to‑shift communications and weekend operations, partnering closely with weekend leadership.

 Qualifications:

•  Associate degree or equivalent warehouse lead experience required; Bachelor’s degree preferred.
• 1+ year of warehouse/logistics or manufacturing experience.
• 3+ years of leadership/supervisory experience required.
• Proficiency in Microsoft Word, Excel, Outlook, and enterprise systems (D365, BPLM, Veeva, etc.).
• Ability to operate material handling equipment (forklifts, PIVs, etc.).
• Must obtain and maintain an Indiana Chauffeur’s License.

 Physical / safety requirements:

•  Ability to stand, sit, or walk for extended periods.
• Ability to lift up to 50 lbs and push/pull heavy equipment (tanks, carts, pallet jacks).
• Use of PPE including safety shoes, gloves, eye and hearing protection.
• Manual dexterity for operating office and warehouse equipment.
• Must be able to bend, twist, stoop, and lift regularly.
• Overtime and weekend work required at times.
• Ability to work in extreme cold environments (–65°C to –85°C).
• Ability to operate PIT equipment for prolonged periods.

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

The Senior Technical Transfer Associate (MSAT) is part of a team of experienced pharmaceutical professionals responsible for the technical onboarding and process development of new drug product projects at Simtra. This includes designing the process(es) required for the new project. The Tech Transfer Senior Associate will work closely with a cross-functional group consisting of Program Management, Sales, Supply Chain, Process Validation, Research and Development (R&D), and others, during development and transfer of new projects to Simtra. This position is 100% onsite at the Bloomington facility and reports to the Sr. Technical Transfer Manager.

The responsibilities:

• Lead the onboarding and process development activities for the manufacture of new drug products, including the supporting development studies
  • Lead the cross-functional team through technical activities, development studies and PPQ batches
  • Create technical transfer documents supporting this goal [Technical Transfer Plan, Process Development studies (i.e. mixing studies, filtration studies, purge studies, etc.), Demonstration batch records, PPQ master batch record]
  • Heavy participation/co-lead with Process Validation representative on PPQ strategy and protocol development
  • Lead during hand-off to the commercial team following PPQ batches
• Provides technical support to daily manufacturing operations while being visible on the manufacturing floor and resolving issues during manufacturing
• Leads process improvement activities
• Independently conduct Non-Conformance Report (NCR) investigations and create, provide ownership, and implementation of Corrective Actions/Preventive Actions (CAPA)
• Change Control Management (CCM) owner and impact assessment
• Ownership of Fill Volume Dosing Qualification (FVOQ) documentation
• Critical evaluation of product impact and responsible for advising if product meets release criteria and regulatory requirements
• Participates in new project reviews to determine acceptable fit
• Reviews Master Batch Records of junior colleagues and provides guidance
• Independently represents Simtra in regulatory, client and internal audits as product/process Subject Matter Expert (SME). Ownership of audit responses and related CAPAs
• Participates independently in client calls and on-site visits to discuss and set strategy for projects and issue resolutions
• Standard Operating Procedures (SOP) owner & process subject matter expert (SME)
• Perform filter troubleshooting
• Develop and present in-depth SME courses on pharmaceutical industry topics
• Mentors new hires in Technical Services Department and helps with training and on-boarding

Required qualifications:

• BS degree, preferably in a science or engineering related field
• 7+ years pharmaceutical manufacturing experience
• 3+ years of applicable Technical Transfer/Process Development experience
• In-depth knowledge of systems and equipment - including scales, mixing systems and mixing monitoring methods, aseptic formulations, fill volume limit setting, disposable formulation technology, homogeneity testing, control charting, identification and response to trends
• Expertise in aseptic processing, sterile filtration, and Process Validation
• Microsoft Office Suite advanced proficiency Word, Excel, and Outlook
• Knowledge and ability to use enterprise software (JDE, BPLM, Minitab, Trackwise, etc.)

Physical / safety requirements:

• Duties will require overtime work on occasion, including nights and weekends
• Position requires sitting for long hours but may involve walking or standing for periods of time
• Must be able to qualify for Grade A/B area gowning
• Must be able to wear applicable personal protective equipment (PPE)

In return, you’ll be eligible for [1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • Short and Long-Term Disability Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
• Additional Benefits
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/24

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
                                                                                                                                                            
EEO is the Law 
EEO is the law - Poster Supplement 
Pay Transparency Policy

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:

https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

As an Aseptic Equipment Lead (AEL), you’ll be at the heart of our sterile manufacturing operations. You’ll own the setup, performance, and optimization of a key aseptic filling line during your shift—making a direct impact on production success, product quality, and team efficiency. Working closely with Engineering, Maintenance, and Filling Operators, you’ll be the go‑to expert for the equipment in your area and a driving force behind continuous improvement.

 Schedule: 6am - 4:30pm (Monday - Thursday)

The responsibilities:

• Become the subject‑matter expert for your assigned filling line—whether syringe or vial equipment—and its supporting systems such as component washers, depyrogenation tunnels, filling and stoppering machines, cappers, tray loaders, and lyophilizer loading/unloading systems.
• Lead troubleshooting efforts by investigating complex issues, identifying root causes, and implementing effective, long‑term solutions.
• Monitor and evaluate line performance to support Out of Control Limit Reports (OCRs) and ensure inspection readiness.
• Analyze trends to uncover opportunities to reduce downtime, improve operator efficiency, and boost product yield.
• Standardize and train others on equipment setup and basic troubleshooting, ensuring operators and production leaders feel confident and capable.
• Partner with Line Engineers and Operational Excellence teams to champion improvements that enhance safety, quality, efficiency, and overall team performance.
• Maintain Grade A/B aseptic gowning certification and successfully complete operator qualification/media fill requirements.

The work environment:

You’ll work in a fast‑paced, hands‑on sterile manufacturing environment with direct interaction with complex automated equipment. Time is spent within Grade A–D cleanroom spaces, supporting the critical production of high‑quality sterile products.

Required qualifications:

• High school diploma or GED.
• At least 3 years of manufacturing experience.
• Proficiency in Microsoft Word, Excel, and Outlook, plus the ability to learn enterprise systems such as Veeva, D365, and Blue Mountain.
• Strong mechanical aptitude and the ability to troubleshoot in a hands‑on, equipment‑focused environment.

Physical / safety requirements:

• Ability to lift up to 50 lbs.
• Ability to stand and/or walk for extended periods.
• Work in Grade A–D controlled environments for long durations.
• Frequent use of hands and fingers for precise equipment manipulation.

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

The Sr. Calibration Technician performs calibrations and maintains the calibration scheduling system to confirm facility requirements.  It reports to the Calibration Manager.

The responsibilities:

• Test and calibrate measuring and test instruments for conformance to Standard Operating Procedures
• Set up test equipment, measures accuracy of instruments used to record various parameters (voltage, current, heat, flow, pressure, etc.)
• Adjust/repair instruments to meet calibration standards
• Coordinates instrument re-certification with outside standards laboratories, which includes inspections and documentation reviews on those instruments.
• Maintain calibration scheduling database and required documentation.
• Serve as a technical resource on calibration issues including investigation of out-of-tolerance events.
• Rotate on-call for off-hours and weekend support. Duties may also require overtime and weekends.

Required qualifications:

• High school diploma required (Associates Degree preferred)
• 5+ year(s) calibration experience or related field with proven problem-solving skills in pharmaceutical industry
• Basic understanding of calibration with an ability to deal with moderately complex processes and procedures
• Must be able to demonstrate judgment and initiative in problem resolution
• Must be able to work unsupervised
• Good communication skills and detail oriented
• Working knowledge of 21CFR and cGMP regulations
• Work experience in a clean room environment a plus
• Duties may require overtime work, including nights and weekends

Physical / safety requirements:

• Must be able to lift, push/pull, and carry up to 55 pounds
• Must wear personal protective equipment (PPE), including respirator
• May be required to work with pressurized equipment, hot surfaces
• May be required to work in confined spaces
• Position requires standing for long hours
• Ability to qualify for Grade B gowning

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

We are seeking a detail-oriented and highly organized Supply Chain Planner to develop, manage, and maintain a workable production plan that supports both customer needs and business objectives. This role partners closely with cross-functional teams to balance capacity, demand, and operational priorities in a fast-paced, constantly evolving environment.

The ideal candidate is analytical, collaborative, and able to effectively manage multiple priorities with minimal supervision.

The responsibilities:

• Generate and present short‑term capacity and resource analyses.
• Evaluate intermittent demand and customer requests to identify the best opportunities for scheduling filling and finishing activities.
• Maintain a balanced 90‑day manufacturing plan focused on labor and equipment utilization, while accounting for preventive maintenance and other non-production activities.
• Collaborate with Manufacturing to develop and maintain an executable production plan.
• Open and manage work orders in the ERP system.
• Coordinate start dates for Filling and Finishing work orders to ensure smooth material flow.
• Prepare monthly performance metrics (e.g., Schedule Adherence, S&OP, budgeted volume).
• Manage and maintain master data including project codes, routings, turn/run times, and other planning elements.
• Coordinate internal non‑product production activities, including scheduling, work order management, and reporting.
• Serve as the system owner for the internal Compass database, ensuring data accuracy and integrity.
• Create and maintain the shipping schedule.

Qualifications:

• Bachelor’s degree required.
• Minimum of 2 years of professional experience; experience in contract manufacturing a plus.
• Solid understanding of business operations and strategic planning.
• Strong ability to design reports, analyze data, and present findings.
• Exceptional attention to detail and organizational skills.
• Ability to manage multiple priorities independently while following established guidelines and processes.
• Strong problem‑solving and analytical skills.
• Self-motivated with the ability to identify process gaps and recommend improvements.
• Strong interpersonal and communication skills; able to work effectively across diverse functional teams.
• Team-oriented and adaptable in a fast-paced, changing environment.
• Proficient in written and verbal communication; strong arithmetic skills.
• Expert-level proficiency in Microsoft Excel required.
• Proficient with Microsoft Word, Excel, Outlook, and enterprise systems such as JDE, BPLM, Pilgrim, Trackwise, or similar.

Physical / safety requirements:

• Ability to work overtime, including evenings and weekends, as needed.
• Able to sit for extended periods; occasional walking or standing may be required.
• Manual dexterity to operate office equipment.
• Occasional lifting or moving of objects up to 20 pounds.

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

The role:

The Manufacturing Manager is responsible for all production activities on a shift, supporting multiple filling lines manufacturing injectable drug products. The Manufacturing Manager leads a team of Manufacturing Supervisors and reports directly to the Senior Manufacturing Manager (Building Manager). The manager will lead, organize, and manage personnel and activities in all manufacturing activities under cGMP regulations, to serve as the primary contact for manufacturing related communications on the shift, and to provide guidance to the leadership team to ensure consistent execution and improvement of the manufacturing process. The Manufacturing Manager creates an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.

Its responsibilities:

• Lead a team of manufacturing supervisors to compliantly meet the production schedule in controlled environments.
• Partners with peers in other manufacturing buildings and on other shifts to ensure the site schedule is maintained.
• Interviews, hires, coaches, and develops staff. Provides timely and accurate feedback recognizing good / poor performance. Establishes clear direction and priorities for building leadership team, empowers team members to obtain results that support strategic objectives.
• Develop, deploy, and properly manage processes to consistently “run the business” and “improve the business”.
• Partners with quality and technical services leaders to either author, review and / or approve investigations and drive timely closure to meet client delivery dates.
• Approves SOP’s, validations, and protocols in a timely manner.
• Partners with client teams to support client projects and client audits.
• Provide technical expertise and resources, cooperating and coordinating with Quality, Program Management, Engineering, Maintenance and Technical Services.
• Ensures organization’s budget is met and maintains expenses within the plan.
• Regularly interacts with senior management and client representatives on matters concerning several functional areas, divisions, and/or customers.
• Takes personal responsibility to develop, deploy, and properly manage a culture of safety and working conditions. Adheres to all environmental, health, and safety SOPs and policies. Actions and decisions must reflect that our team member’s safety is always first on our minds.
• Leads in such a manner that inspires the trust of his / her subordinates, peers, and superiors. Must lead as a role model of respect and integrity.
• Must be a lean leader. Instills a culture of “go and see”. Engage with team members where the work is done. Embrace and adopt best practices. Setting the example is not the only thing in influencing others, it is the main thing.

Desirable qualifications:

• Bachelor’s degree strongly preferred, with emphasis on a scientific or engineering discipline.
• Minimum 5 years’ experience in all aspects of the aseptic pharmaceutical manufacturing process.
• Must have knowledge of GMPs and worldwide regulatory agency guidelines.
• Minimum 3 years in a leadership role, preferably in parenteral manufacturing.
• Lean Manufacturing experience required (i.e. value stream mapping, leading kaizen events to drive positive change on the floor, and teaching people to think)
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, MAXIMO, Trackwise, etc.)

Physical / safety requirements:

• Ability to stand for extended periods of time
• Physical coordination/flexibility to allow gowning for clean room environments
• Utilize applicable personal protective equipment, including safety shoes/toe caps, gloves, eye protection, heat resistant wear and hearing protection
• Dexterity and physical condition to perform some level of repetitive motion tasks
• Ability to wear respirator usage when product or task requires
• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Must be able to gown qualify for Grade A/B areas (filling)
• Position may require sitting for long hours

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

As an Aseptic Equipment Lead (AEL), you’ll be at the heart of our sterile manufacturing operations. You’ll own the setup, performance, and optimization of a key aseptic filling line during your shift—making a direct impact on production success, product quality, and team efficiency. Working closely with Engineering, Maintenance, and Filling Operators, you’ll be the go‑to expert for the equipment in your area and a driving force behind continuous improvement.

 Schedule: 2pm - 12:30am (Monday- Thursday)

The responsibilities:

• Become the subject‑matter expert for your assigned filling line—whether syringe or vial equipment—and its supporting systems such as component washers, depyrogenation tunnels, filling and stoppering machines, cappers, tray loaders, and lyophilizer loading/unloading systems.
• Lead troubleshooting efforts by investigating complex issues, identifying root causes, and implementing effective, long‑term solutions.
• Monitor and evaluate line performance to support Out of Control Limit Reports (OCRs) and ensure inspection readiness.
• Analyze trends to uncover opportunities to reduce downtime, improve operator efficiency, and boost product yield.
• Standardize and train others on equipment setup and basic troubleshooting, ensuring operators and production leaders feel confident and capable.
• Partner with Line Engineers and Operational Excellence teams to champion improvements that enhance safety, quality, efficiency, and overall team performance.
• Maintain Grade A/B aseptic gowning certification and successfully complete operator qualification/media fill requirements.

The work environment:

You’ll work in a fast‑paced, hands‑on sterile manufacturing environment with direct interaction with complex automated equipment. Time is spent within Grade A–D cleanroom spaces, supporting the critical production of high‑quality sterile products.

Required qualifications:

• High school diploma or GED.
• At least 3 years of manufacturing experience.
• Proficiency in Microsoft Word, Excel, and Outlook, plus the ability to learn enterprise systems such as Veeva, D365, and Blue Mountain.
• Strong mechanical aptitude and the ability to troubleshoot in a hands‑on, equipment‑focused environment.

Physical / safety requirements:

• Ability to lift up to 50 lbs.
• Ability to stand and/or walk for extended periods.
• Work in Grade A–D controlled environments for long durations.
• Frequent use of hands and fingers for precise equipment manipulation.

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

A Utilities Engineer is responsible for continuous improvement, technical support and troubleshooting as required on critical utility systems. This role will be responsible for maintenance programs for all existing critical utilities (preventive, reactive, corrective and predictive) and improvement projects, including managing vendor relations, procurement, installation, and functional testing to achieve both budget and timeline requirements. This position is 100% onsite at the Bloomington facility and reports to the Manager of Process Engineering.

The Responsibilities:
• Support in the design and maintenance of utilities and associated systems - including, but not limited to, cooling towers, compressed air generation and distribution systems, chilled water generation and distribution systems, air handling units (AHUs) supporting aseptic processing operations, electrical distribution and backup systems, boiler/steam generation and distribution systems, clean steam generation, fire suppression, water for injection (WFI) production and distribution to points of use
• Monitor and troubleshoot utilities systems and associated equipment to identify and resolve any issues promptly to minimize downtime
• Responsible for and active supervision of technical building systems in the GMP environment, including electricity/emergency power, refrigeration, cooling and vacuum technology
• Detailed planning and implementation during shutdowns, new installations, and process optimization of utilities systems
• Create cGMP/GDP-compliant lifecycle documentation, maintenance, qualifications procedures and operating instructions, including change controls as necessary
• Subject matter expert for building monitoring and work order systems
• Continuous improvement of facilities and processes using LEAN tools and methodologies
• Collaborate with cross-functional teams to ensure utilities systems are integrated effectively into manufacturing processes
• Develop and execution of preventative maintenance plans for utilities systems and associated equipment to ensure optimal performance and compliance
• Stay current with industry regulations and best practices, ensuring utilities systems meet all safety and quality standards
• Provide technical expertise and guidance to junior engineers and technicians within the teams
• Drive continuous improvement initiatives to enhance the efficiency, reliability, and sustainability of utilities systems and associated equipment
• Preparation and maintenance of documentation, including standard operating procedures, equipment manuals, and maintenance records
• Utilize root cause analysis techniques to investigate process and equipment issues and sustainable and preventatives actions
• Own the qualified state of the critical utilities equipment

What you'll bring:
• BS degree in Engineering or Technology required
• 3+ years’ experience in a pharmaceutical industry or in a highly regulated role
• Working knowledge of high and low voltage electrical switchgear and distribution systems
• Working knowledge of common project management tools
• Experience with generation, operation, and use of clean steam and WFI generation systems
• Understanding of controls, wiring and circuitry
• Experience with hydraulics & pneumatics, and operation of air handling systems
• Experience with automation and programmable logic control (PLC) systems

Physical / safety requirements:

• Ability to wear required personal protective equipment (PPE) 
• Ability to work overtime, nights, and weekends as business needs require 
• Must be able to lift up to 50lbs
• Must be able to gown qualify for Grade A/B area
• Position requires sitting or standing for long hours.

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

The Filling & Capping Operator (Operator II & III) position supports aseptic filling operations by staging and delivering components, conducting in-process testing, operating fill line equipment, conducting inspections of filled units, batch count reconciliation, compliant gowning, setup and operation of aseptic filling equipment, aseptic movement of components and terminal sterilization in conformance with current Good Manufacturing Practices and Good Documentation Practices (cGMP/GDP) standards.  The Operator will also initiate minor revisions to existing documents and troubleshoot simple processes / equipment failures. The Operator may be required to cross-train as a support Operator for additional areas. This position reports to the Manufacturing Supervisor. 

Shift structures:

1: M-Th 7:00 – 16:00

2: M-Th 15:00 – 00:00

3: M-Th  23:00 - 8:00

4: Fr-Su 7:00 – 19:30

5: Fr-Su 19:00 – 7:30

Essential Duties and Responsibilities (these are primary responsibilities of the role and the incumbent will perform other duties as assigned): 

• Understand and follow current Good Manufacturing Practices (GMP) 

• Understand and follow current Good Documentation Practices (GDP) 

• Perform routine cleanup, line clearances, and sanitizations as assigned by area supervision to maintain cGMP compliance within the Cleanroom work areas.  Perform sanitizations in a timely and effective manner in accordance with cGMPs and Simtra procedures, maintaining production schedule.   

• May be required to cross train as a support operator to assist additional manufacturing areas. 

• Maintain organization at all times within the classified areas to ensure equipment segregation, readiness and to prevent any contamination or rejection of batches. 

• Perform routine verification of equipment and instruments. 

• Setup and operate aseptic filling equipment for routine aseptic processes, performed with proper aseptic technique to prevent negative safety, identity, strength, purity and quality impact to the batch.     

• Perform routine operations utilizing aseptic formulation and filling equipment in Cleanroom areas.   

• Perform environmental monitoring; including fingertip, contact, and fallout plates. 

• Assist in the training and development of other team members 

• Required to maintain attendance in accordance with the Bloomington Attendance Policy 

• Scheduled weekend overtime may be required  

• Successful operator qualification/media fill performance required to achieve increased operator levels 

Job Requirements (Education, Experience and Qualifications): 

• High school diploma or GED required, 6 months of previous Pharmaceutical or Manufacturing experience preferred. 

• Must be able to understand, speak, read and write English in order to comply with necessary SOP’s, job-specific training materials, GMP’s, and other manuals. 

• Basic Computer skills in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: Veeva, D365, Blue Mountain, etc.) 

• Must have the ability to work effectively in a ”hands on environment” capable of troubleshooting complex equipment and systems  

• Competency in operation of multiple types of equipment related to the manufacturing operations as well as hand operated equipment including, but not limited to, such things as calipers, scales, gauges, and other measuring devices.  Ability to demonstrate proficiency in reading equipment drawings.  Ability to work safely with equipment under pressure. 

Physical / Safety Requirements 

• Must be able to lift and carry up to 50 lbs, and push and pull up to 50 lbs. 

• Extended periods of standing and/or walking 

• Extended periods in Grade A, B, C, D production environments 

• Use of hands and fingers to manipulate equipment is required 

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements. Employees must be in their current position for a minimum of twelve (12) months and be in good standing before applying for other internal opportunities.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

The role:

The Quality Associate I is a member of the Quality Assurance Line Operations Team. They maintain quality oversight of the manufacturing areas by working closely with manufacturing personnel and performing various checks during manufacturing processes. They also assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Simtra Standard Operating Procedures. This position strives for continuous improvement of processes and contributes to creating an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.

The responsibilities:

• Ensures compliance with all worldwide regulatory agency requirements and company-specific regulations related to quality of product and employee safety.
• In-process review of records to ensure they are complete, accurate and compliant with current Good Manufacturing Practices (cGMP) requirements. Records include batch records and other documents involved in the aseptic processing of drug product.
• Reports errors, deficiencies, discrepancies and observations to management. May stop operations when product safety is or may be compromised.
• Performs Quality functions in classified areas, including production oversight, manufacturing process assessments, and aseptic intervention oversight.
• Works in collaboration with management teams to prepare for internal and external audits. Assists with timely closure of audit observations and CAPAs.
• Initiates and authors Nonconformance Reports and corrective and preventative action responses.
• Conducts bi-annual inspections of classified areas in preparation for facility shutdown periods.
• Initiates standard operating procedure (SOP) revisions as needed to support continuous improvement.
• Ensures that SOPs are current and effective and that staff performs routine tasks according to SOP through direct observation.

The requirements:

• Bachelor’s degree (preferred science discipline), or Associate’s degree with at least 1 year of Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience, or high school diploma/GED with at least 2 years Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, SAP, Maximo, TrackWise, etc.)

Physical / Safety Requirements

• Must wear appropriate PPE as required for various manufacturing areas
• Must be able to gown qualify for Grade A/B areas.
• Duties will require overtime work, including scheduled weekend shifts
• Use of hands and fingers to manipulate office equipment is required
• Position requires standing for long hours, but may require sitting for periods of time.

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance 
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

The role:

The Development Scientist role is responsible for independently managing development projects and investigating improvements of technology that advance formulation development, process development, and manufacturing at Simtra. This role is also responsible for training scientists in formulation and process development for injectable products. The scientist reports directly to the Global Senior Scientist.

The responsibilities:

• Independently design and manage research studies that demonstrate the scientific capabilities at Simtra, solve challenging process development problems for potential clients, and that can be published in peer-reviewed journals and presented at scientific meetings.
• Collaborate with scientists in Bloomington and Halle to introduce potential new clients to Simtra, learn about their molecule / project, and propose possible directions for developing the product.
• Collaborate with the development scientists at both sites to overcome possible challenges in the development of a product.
• Investigate possible solutions to challenges that may be encountered during product development.
• Develop and utilize a digital twin during conjugation and purification of antibody drug conjugates and possibly other areas of development and manufacturing.
• Develop, implement, and optimize techniques and procedures in the field of formulation and lyophilization development or analytical development and validation. Develop a deeply differentiated technical skill set to contribute to department capabilities for product development.
• Sought out by other teams and individuals to offer technical advice; may act as coach, mentor, supervisor, and technical advisor to junior members within the discipline.
• Implement new or improved techniques and procedures around specific tasks. Apply state-of-the-art techniques in the area of expertise to develop new or improved products.
• Apply specialized technical and theoretical knowledge in creative ways to a broad range of difficult problems. Contribute to technical feasibility analysis, which incorporates multiple disciplines where new and unproven methods and technologies are required. Generate innovative solutions to highly complex problems where little clear precedence exists. Incorporate advanced theories, methods and technologies from around the world to develop new innovative products/processes.
• Examine the use of predictive modeling and data analysis for formulation and process development to improve platforms for client projects.
• Utilize operational excellence and statistical tools to improve experimental design, process efficiency, or quality/compliance.
• In addition to having an in-depth knowledge and understanding of GxP and related regulations and guidance, is able to provide expert insights into such regulations so as to facilitate efficient product registration and/or is an active participant in the generation, review, adoption and interpretation of such regulations.
• Maintain current knowledge of relevant quality and other regulatory requirements related to research and development (product development, design and safety) to ensure compliance in all research, data collection and reporting activities.
• Investigate routes of collaborating with start-ups or other companies to obtain funding for research and development initiatives.
• Interact and collaborate with Sales, Marketing, and Program Management groups to professionally introduce potential new clients to Simtra Development and Pre-Commercial Services as well as other teams and capabilities.
• Develop and conduct scientific training programs in formulation and process development for BDEs, PM, and clients in collaboration with business development.

Required Qualifications:

• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Science or a scientific discipline with at least 15 years of relevant experience, or MS with at least 10 years, or a scientist with a PhD in Pharmaceutical science, Chemical Engineering, or a scientific discipline.
• Lab experience includes research in GMP environment, leadership of technical teams, and project management experience is desirable.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: TCU, Trackwise, etc.)
• Strong statistical skills and ability to use standard statistical software (examples include MiniTab, JMP) preferred.

Physical / Safety Requirements:

• Wear all PPE required by EHS (typically safety glasses, lab coat, gloves but may include a respirator).
• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Position requires sitting for long hours, but may involve walking or standing for periods of time.
• This position requires handling of laboratory chemicals
• Must be able to qualify for 20/25 corrected vision.

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

The Filling Group Leader is a member of the Manufacturing Leadership Team reporting directly to the Manufacturing Supervisor.  They provide direct support to manufacturing to ensure that finished products meet the required specifications by coordinating activities of Filling Operators who perform in the manufacturing areas.  The Filling Group Leader provides decision-making and oversight to ensure compliance to all regulatory agency regulations and guidelines and to Simtra Standard Operating Procedures.  This position fully supports and drives quality operations on the production floor and communicates effectively with production team members, multiple levels of management, and other customer support departments.  The Filling Group Leader creates an environment where teamwork, productivity, safety, identity, strength, purity, and quality (SISPQ) are reflected in the finished product. 

This position is required to work all designated plant holidays.

3rd Shift - Monday/Friday 10PM-8:30AM

The responsibilities:

• Delegate, coordinate, and schedule activities of assigned team members.
• Recommend measures to improve performance and increase efficiency
• Train and mentor other team members.
• Troubleshoot process problems and respond to process alarms.
• Participate on Continuous Improvement teams.
• Assist in developing/reviewing batch records of new and existing projects.
• Assist in establishing and orienting new projects for production
• Review project plans and batch records prior to operations; monitor assigned team’s documentation in logbooks and batch records.  
• Organize and coordinate general cleaning and sanitizations throughout all filling suites.
• Identify potential causes and verify/eliminate each one to determine the true root cause behavior
• Required to maintain attendance in accordance with the Bloomington Attendance Policy
• Scheduled weekend overtime will be required

The work environment:

Classified pharmaceutical environment wearing required gowning. Must be able to work safely with materials required to produce pharmaceutical products, including chemicals, compounds, glassware and sanitization solutions.  Must be able to occasionally (1-33% of the time) work in a confined/clustered work space.  

Desirable qualifications:

To perform this job successfully an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals to perform the essential functions: 

• Ability to work independently
• Good communication skills
• Good documentation skills, including legible handwriting
• Good interpersonal skills
• Basic computer skills
• Basic math skills
• Knowledge of aseptic manufacturing practices
• Knowledge of standard operating procedures, specifications, and job-specific training materials/Subject Matter Expert
• Requires the operations of multiple types of equipment related to the manufacturing operations as well as hand operated equipment including, but not limited to, such things as calipers, scales, gauges, and other measuring devices

Physical / safety requirements:

• Occasional (1-33%)
• Sitting, climbing stairs and ladders, balancing, kneeling, operating controls
• Lifting and carrying up to 70 lbs
• Pushing and pulling up to 35 lbs
• Frequent (34-66%)
• Standing, walking, reaching forward and overhead, stooping, crouching, 
• Lifting and carrying up to 37 lbs
• Constant (67-100%)
• Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping

Additional requirement(s):

• High school diploma or GED required
• 6 months of previous Pharmaceutical or Manufacturing experience preferred.
• Final candidates for Group Leader will be required to pass a post offer/pre-employment job placement examination which will test the physical capabilities to perform the essential functions of the job.

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.                                                                                                                                          

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Privacy Policy:
Privacy Policy — Simtra BioPharma Solution

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

We are looking for Automation Engineers (level depends on experience) that are responsible for leading the identification, implementation, optimization, and maintenance of process automation and controls systems in pharmaceutical processing, packaging, and facilities. These engineers ensure efficient, quality, functional, and compliant process automation systems and supports engineering systems, capital projects, technical services, and plant support, as applicable. These positions are 100% onsite at the Bloomington, Indiana facility and reports directly to the Sr. Manager, Automation Engineering.

The responsibilities:

• Lead various aspects of support needed in the design, development, and implementation of the site process automation and controls systems
• Develop, modify, and troubleshoot PLC & HMI programs
• Specify and configure ins
• Identify and drive improvement opportunities for equipment, instrument, and process optimization, efficiency, and cost reduction through automation technologies and lead initiatives to implement projects
• Lead the deployment of the full system lifecycle for process automation and control systems including the design, assessment, selection, commissioning, validation, and implementation of systems
• Troubleshoot automation and controls systems issues, conduct root causes analysis, and implement corrective actions to minimize downtime and ensure continuous operations
• Conduct risk assessments of automation and controls systems
• Ensure automation and controls systems meet regulatory requirements by conducting and assisting with validation activities

Required qualifications:

• Level I: BS in Engineering (Computer, Electrical, Computer Science, Systems Engineering and Design, or related field) or 6+ years of relevant experience
• Level II: BS in Engineering (Computer, Electrical, Computer Science, Systems Engineering and Design, or related field) or 10+ years of relevant experience
• Level III/Sr: BS in Engineering (Computer, Electrical, Computer Science, Systems Engineering and Design, or related field) and 6+ years of relevant experience
• Level IV/Principal: BS in Engineering (Computer, Electrical, Computer Science, Systems Engineering and Design, or related field) and 10+ years of relevant experience
• Level V/Sr. Principal: BS in Engineering (Computer, Electrical, Computer Science, Systems Engineering and Design, or related field) and 15+ years of relevant experience
• Work experience in process automation and controls systems (including programming PLCs, SCADA, and HMI systems) in pharmaceutical and/or manufacturing environments
• Experience in reading and interpreting electrical schematics and Process & Instrumentation Diagrams (P&IDs)
• Experience in Ignition SCADA/HMI
• Knowledge of coding in Rockwell and Siemens (PLCs and HMIs)
• Knowledge of automation and controls hardware and software systems
• Ability to prioritize projects and workload
• Excellent verbal communication and technical writing skills

Physical/safety requirements:

• Duties may require overtime work, including nights and weekends
• Position requires sitting for long hours, but may also involve walking or standing for long periods of time
• Variable travel of 0-10% could be expected
• Must be able to lift, push, pull, and carry up to 50 lbs
• Must be able to lift 20 lbs overhead
• Must be able to wear personal protective equipment (PPE), as required

In return, you’ll be eligible for [1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

For over 65 years, pharmaceutical and biotech companies have partnered with Simtra BioPharma Solutions (Simtra) to bring their sterile injectable products to market.

Simtra is a world-class Contract Development Manufacturing Organization with facilities in Indiana, US and Halle/Westfalen, Germany.  We offer a wide-range of delivery systems including prefilled-syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials, and sterile crystallization.  Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, at Simtra, there is a strong emphasis on quality and continuous improvement.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support, and secondary packaging.

In addition to unmatched expertise and experience, we offer a uniquely collaborative approach.  Clients look to Simtra as an extension of their own companies.

It is very rewarding industry to work in.  Our teams are driven to help clients scale, innovate, and bring-life changing medicines to patients worldwide.

The Principal Technical Transfer Representative is part of a team of experienced pharmaceutical professionals responsible for the technical onboarding and process development of new drug product projects at Sintra BPS. This includes designing the manufacturing process(es) required for drug products. The Principal Technical Transfer Representative will work closely with a cross-functional group consisting of Program Management, Sales, Supply Chain, Process Validation, Research and Development (R&D), and others, during development and transfer of new projects. This position reports to the Sr. Manager, Technical Transfer.

What you'll be doing:

• Lead the onboarding and process development activities & tasks for the manufacture of new drug products, including the supporting development studies
  • Serve as the lead technical expert among a cross functional team
  • Lead the cross functional team through technical activities, development studies and PPQ batches
  • Create technical transfer documents supporting this goal [Tech. Transfer Plan, process development studies (i.e. mixing studies, filtration studies, purge studies, etc.), demonstration batch records, PPQ master batch record]
  • Heavy participation / co-lead with Process Validation Representative on PPQ strategy and protocol development
  • Lead during hand-off to the commercial team following PPQ batches
• Provides technical support to daily Manufacturing operations by being visible on the manufacturing floor, resolves issues during manufacturing and leading process improvement activities
• Conduct Non-Conformance Report (NCR) investigations without assistance, as well as creation, ownership and implementation of Corrective Actions/Preventive Actions (CAPA)
• Change Control Management (CCM) owner and impact assessment
• Ownership of fill volume dosing qualifications (FVOQ)
• Critical evaluation of product impact and responsible for advising if product meets release criteria and regulatory requirements
• Participates in new project reviews to determine acceptable fit
• Reviews Master Batch Records of junior colleagues and provides guidance
• Technical representative in regulatory, client and internal audits as product/process Subject Matter Expert (SME), and ownership of audit responses and related CAPAs]
• Participates independently in client calls and on-site visits to discuss and set strategy for projects and issue resolutions
• SOP owner & process SME
• Perform filter troubleshooting
• Develops and presents in-depth SME courses on pharmaceutical industry topics
• Mentors new hires in Technical Services and helps with training and on-boarding
   

What you'll bring:

• BS degree required (preferably in a science or engineering related field
• 6+ years pharmaceutical manufacturing experience (preferably in a CDMO)
• Requires in depth knowledge of systems and equipment, including: scales, mixing systems and mixing monitoring methods, aseptic formulations, fill volume limit setting, disposable formulation technology, homogeneity testing, control charting, identification and response to trends
• Experience in aseptic processing, sterile filtration, and process validation
• MS Office Suite advanced proficiency
• Experience using Enterprise software (i.e., JDE, BPLM, MiniTab, Trackwise, etc.)

Physical / Safety Requirements:

• Require overtime work on occasion, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Position requires sitting for long hours, but may involve walking or standing for periods of time
• Must be able to qualify for Grade A/B area gowning
• Must be able to wear applicable personal protective equipment (PPE)

#LI-SB1

Equal Employment Opportunity

Simtra is an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
                                                                                                                                                               
EEO is the Law 
EEO is the law - Poster Supplement 
Pay Transparency Policy

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:
https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

As an Aseptic Equipment Lead (AEL), you’ll be at the heart of our sterile manufacturing operations. You’ll own the setup, performance, and optimization of a key aseptic filling line during your shift—making a direct impact on production success, product quality, and team efficiency. Working closely with Engineering, Maintenance, and Filling Operators, you’ll be the go‑to expert for the equipment in your area and a driving force behind continuous improvement.

 Schedule: 7pm-7:30am (Friday - Monday)

The responsibilities:

• Become the subject‑matter expert for your assigned filling line—whether syringe or vial equipment—and its supporting systems such as component washers, depyrogenation tunnels, filling and stoppering machines, cappers, tray loaders, and lyophilizer loading/unloading systems.
• Lead troubleshooting efforts by investigating complex issues, identifying root causes, and implementing effective, long‑term solutions.
• Monitor and evaluate line performance to support Out of Control Limit Reports (OCRs) and ensure inspection readiness.
• Analyze trends to uncover opportunities to reduce downtime, improve operator efficiency, and boost product yield.
• Standardize and train others on equipment setup and basic troubleshooting, ensuring operators and production leaders feel confident and capable.
• Partner with Line Engineers and Operational Excellence teams to champion improvements that enhance safety, quality, efficiency, and overall team performance.
• Maintain Grade A/B aseptic gowning certification and successfully complete operator qualification/media fill requirements.

The work environment:

You’ll work in a fast‑paced, hands‑on sterile manufacturing environment with direct interaction with complex automated equipment. Time is spent within Grade A–D cleanroom spaces, supporting the critical production of high‑quality sterile products.

Required qualifications:

• High school diploma or GED.
• At least 3 years of manufacturing experience.
• Proficiency in Microsoft Word, Excel, and Outlook, plus the ability to learn enterprise systems such as Veeva, D365, and Blue Mountain.
• Strong mechanical aptitude and the ability to troubleshoot in a hands‑on, equipment‑focused environment.

Physical / safety requirements:

• Ability to lift up to 50 lbs.
• Ability to stand and/or walk for extended periods.
• Work in Grade A–D controlled environments for long durations.
• Frequent use of hands and fingers for precise equipment manipulation.

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

The role:

The Quality Associate I is a member of the Quality Assurance Line Operations Team reporting directly to the Quality Line Operations Lead. They maintain quality oversight of the manufacturing areas by working closely with manufacturing personnel and performing various checks during manufacturing processes. They also assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Simtra Standard Operating Procedures. This position strives for continuous improvement of processes and contributes to creating an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.

The responsibilities:

• Ensures compliance with all worldwide regulatory agency requirements and company-specific regulations related to quality of product and employee safety.
• In-process review of records to ensure they are complete, accurate and compliant with current Good Manufacturing Practices (cGMP) requirements. Records include batch records and other documents involved in the aseptic processing of drug product.
• Reports errors, deficiencies, discrepancies and observations to management. May stop operations when product safety is or may be compromised.
• Performs Quality functions in classified areas, including production oversight, manufacturing process assessments, and aseptic intervention oversight.
• Works in collaboration with management teams to prepare for internal and external audits. Assists with timely closure of audit observations and CAPAs.
• Initiates and authors Nonconformance Reports and corrective and preventative action responses.
• Conducts bi-annual inspections of classified areas in preparation for facility shutdown periods.
• Initiates standard operating procedure (SOP) revisions as needed to support continuous improvement.
• Ensures that SOPs are current and effective and that staff performs routine tasks according to SOP through direct observation.

The qualifications:

• Bachelor’s degree (preferred science discipline), or Associate’s degree with at least 1 year of Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience, or no degree with at least 2 years Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, SAP, Maximo, TrackWise, etc.)

Physical / Safety Requirements:

• Must wear appropriate PPE as required for various manufacturing areas
• Must be able to gown qualify for Grade A/B areas.
• Duties will require overtime work, including scheduled weekend shifts
• Use of hands and fingers to manipulate office equipment is required
• Position requires standing for long hours, but may require sitting for periods of time

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
                                                                                                                                                            
EEO is the Law 
EEO is the law - Poster Supplement 
Pay Transparency Policy

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:

https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

 The Formulation Group Leader is a member of the Manufacturing Leadership Team reporting directly to the Manufacturing Supervisor.  They provide direct support to manufacturing to ensure that finished products meet the required specifications by coordinating activities of Formulation Operators who perform in the manufacturing areas.  The Formulation Group Leader provides decision-making and oversight to ensure compliance to all regulatory agency regulations and guidelines and to Simtra Standard Operating Procedures.  This position fully supports and drives quality operations on the production floor and communicates effectively with production team members, multiple levels of management, and other customer support departments.  The Formulation Group Leader creates an environment where teamwork, productivity, safety, identity, strength, purity, and quality (SISPQ) are reflected in the finished product.

Weekend PM Schedule: Friday-Sunday 7:00pm-7:30am

The responsibilities:

• Prepare media and buffer solutions
• Operate Clean-in-Place (CIP) and Steam-in-Place (SIP) systems
• Operate general production equipment (such as pH and conductivity meters, autoclaves, portable mixers, scales and balances, etc)
• Monitor and record critical process parameters
• Complete all relevant paperwork following GDP/GMP guidelines
• Perform routine maintenance and cleaning of production equipment to maintain in GMP fashion
• Perform sampling using aseptic techniques
• Participate on Continuous Improvement Teams
• Train and mentor other team members
• Write, revise and review pertinent documentation as appropriate
• Troubleshoot process problems and respond to process alarms
• Assist with process/equipment validation and data analysis
• Work with other groups such as maintenance/metrology and calibration to ensure preventative maintenance completion
• Required to maintain attendance in accordance with the Bloomington Attendance Policy
• Scheduled weekend overtime will be required

Work Environment: 

Classified pharmaceutical environment wearing required gowning. Must be able to work safely with materials required to produce pharmaceutical products, including chemicals, compounds, glassware and sanitization solutions.  Must be able to occasionally (1-33% of the time) work in a confined/clustered work space.

Desirable qualifications:

To perform this job successfully an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals to perform the essential functions: 

• Ability to work independently
• Good communication skills
• Good documentation skills, including legible handwriting
• Good interpersonal skills
• Basic computer skills
• Basic math skills
• Knowledge of aseptic manufacturing practices
• Knowledge of standard operating procedures, specifications, and job-specific training materials/Subject Matter Expert
• Requires the operations of multiple types of equipment related to the manufacturing operations as well as hand operated equipment including, but not limited to, such things as calipers, scales, gauges, and other measuring devices

Physical / safety requirements:

• Occasional (1-33%)
• Sitting, climbing stairs and ladders, balancing, kneeling, operating controls
• Frequent (34-66%)
• Standing, walking, reaching forward and overhead, stooping, crouching,
• Pushing and pulling up to 110 lbs
• Lifting and carrying up to 70 lbs
• Constant (67-100%)
• Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping

Additional requirement(s):

• High school diploma or GED required
• 6 months of previous Pharmaceutical or Manufacturing experience preferred.
• Final candidates for Formulation Group Leader will be required to pass a post offer/pre-employment job placement examination which will test the physical capabilities to perform the essential functions of the job.
• Must be able to understand, speak, read and write English in order to comply with necessary SOP’, job-specific training materials, GMP’s, and other manuals.

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.                                                                                                                                          

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Privacy Policy:
Privacy Policy — Simtra BioPharma Solution

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

The Quality Lab Associate I performs entry-level laboratory testing (pH, density, volume, etc.) that requires a variety of chemical, biological, or physical analyses on products/systems in support of the company’s quality program.  This role works as part of the quality unit. This position reports to a Quality Control Chemistry Supervisor.

The responsibilities:

• Operates applicable laboratory equipment (HPLC, UV, Karl Fischer, pH meter, density meter, etc.)
• Performs testing in accordance with technical service studies, experimental batches and development studies
• Performs raw material, in-process, and finished product testing
• Maintain data integrity and ensure compliance with company standard operating procedures (SOPs) and worldwide regulatory agency requirements
• Writes non-conformance reports
• Initiates Laboratory Investigation Reports
• Performs general laboratory/personal area clean-up
• Participates in continuous improvement functions involving teams, which increase efficiency, solve problems, generate cost savings and improve quality
• Performs internal laboratory checklist and audits

The requirements:

• Bachelor’s Degree in Chemistry, or Biological Science with Analytical Chemistry or Laboratory coursework required
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include:  JDE, BPLM, Pilgrim, Trackwise, etc.)
• Knowledge of instrument/software/documentation repair and calibration systems preferred

Physical / safety requirements:

• Must be able to wear personal protective equipment.
• Duties may require overtime work, including nights, holidays, and weekends
• Use of hands and fingers to manipulate office and laboratory equipment is required
• Position may require sitting or standing for long periods of time. 
• This position requires handling of laboratory chemicals
• Must be able to lift 25 lbs.
• Must be able to qualify for 20/25 corrected vision and pass color blindness test

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • Short and Long-Term Disability Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
• Additional Benefits
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

#IND-USOPS

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
                                                                                                                                                            
EEO is the Law 
EEO is the law - Poster Supplement 
Pay Transparency Policy

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:

https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

As an Aseptic Equipment Lead (AEL), you’ll be at the heart of our sterile manufacturing operations. You’ll own the setup, performance, and optimization of a key aseptic filling line during your shift—making a direct impact on production success, product quality, and team efficiency. Working closely with Engineering, Maintenance, and Filling Operators, you’ll be the go‑to expert for the equipment in your area and a driving force behind continuous improvement.

 Schedule: 7am-7:30pm (Friday - Monday)

The responsibilities:

• Become the subject‑matter expert for your assigned filling line—whether syringe or vial equipment—and its supporting systems such as component washers, depyrogenation tunnels, filling and stoppering machines, cappers, tray loaders, and lyophilizer loading/unloading systems.
• Lead troubleshooting efforts by investigating complex issues, identifying root causes, and implementing effective, long‑term solutions.
• Monitor and evaluate line performance to support Out of Control Limit Reports (OCRs) and ensure inspection readiness.
• Analyze trends to uncover opportunities to reduce downtime, improve operator efficiency, and boost product yield.
• Standardize and train others on equipment setup and basic troubleshooting, ensuring operators and production leaders feel confident and capable.
• Partner with Line Engineers and Operational Excellence teams to champion improvements that enhance safety, quality, efficiency, and overall team performance.
• Maintain Grade A/B aseptic gowning certification and successfully complete operator qualification/media fill requirements.

The work environment:

You’ll work in a fast‑paced, hands‑on sterile manufacturing environment with direct interaction with complex automated equipment. Time is spent within Grade A–D cleanroom spaces, supporting the critical production of high‑quality sterile products.

Required qualifications:

• High school diploma or GED.
• At least 3 years of manufacturing experience.
• Proficiency in Microsoft Word, Excel, and Outlook, plus the ability to learn enterprise systems such as Veeva, D365, and Blue Mountain.
• Strong mechanical aptitude and the ability to troubleshoot in a hands‑on, equipment‑focused environment.

Physical / safety requirements:

• Ability to lift up to 50 lbs.
• Ability to stand and/or walk for extended periods.
• Work in Grade A–D controlled environments for long durations.
• Frequent use of hands and fingers for precise equipment manipulation.

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

The Production Technician III provides direct support to equipment in the Packaging production area. This support consists of the initial set-up of equipment prior to batch processing, changeover activities between batch processing, and troubleshooting during batch processing. A Production Technician III reports directly to the Finishing Supervisor, works with various cross-functional teams to maximize equipment efficiencies and provide ideas for continuous improvement opportunities. The Production Technician III must fully
support operations on the production floor and communicate effectively with production team members.

The responsibilities:  

• Analyze machine/line downtime and efficiency information to respond to operational needs
• Communicate equipment issues to subsequent shifts, Supervisor and appropriate personnel via electronic tech report
• Evaluate and implement improvements to all processes associated with the equipment to increase efficiencies and reduce
• Use all available data (downtime reports, OEE, etc.) to understand and target bottlenecks in the process
• Initiate/complete work orders for equipment related problems
• Provide recommendations and implement solutions to equipment/process challenges
• Ensure all setup and changeover activities are complete and accurate, with an emphasis on achieving target changeover times
• Evaluate changeover parts and ensure that appropriate repairs are made between uses or replacement parts are ordered
• Provide training to Machine Operators for general equipment operation, setup, changeover and troubleshooting
• Work with Finishing Training, Supervisors, Machine Operators, to evaluate and improve SOPs
• Provide support during equipment qualification/validation

Desirable qualifications:  

• Associate’s degree in a technical field
• High school diploma or GED required with proven mechanical aptitude.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: Microsoft Dynamics, Veeva, Trackwise, etc.)

Physical / Safety Requirements:

• Must be able to lift, push/pull, and carry up to 50 pounds
• Required to stand for up to 8 hours per day, including constant standing for 2 hours at a time
• Must be able to lift 20 pounds overhead
• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate equipment is required

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.    

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Privacy Policy:
Privacy Policy — Simtra BioPharma Solutions

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

 The Formulation Group Leader is a member of the Manufacturing Leadership Team reporting directly to the Manufacturing Supervisor.  They provide direct support to manufacturing to ensure that finished products meet the required specifications by coordinating activities of Formulation Operators who perform in the manufacturing areas.  The Formulation Group Leader provides decision-making and oversight to ensure compliance to all regulatory agency regulations and guidelines and to Simtra Standard Operating Procedures.  This position fully supports and drives quality operations on the production floor and communicates effectively with production team members, multiple levels of management, and other customer support departments.  The Formulation Group Leader creates an environment where teamwork, productivity, safety, identity, strength, purity, and quality (SISPQ) are reflected in the finished product.

The responsibilities:

• Prepare media and buffer solutions
• Operate Clean-in-Place (CIP) and Steam-in-Place (SIP) systems
• Operate general production equipment (such as pH and conductivity meters, autoclaves, portable mixers, scales and balances, etc)
• Monitor and record critical process parameters
• Complete all relevant paperwork following GDP/GMP guidelines
• Perform routine maintenance and cleaning of production equipment to maintain in GMP fashion
• Perform sampling using aseptic techniques
• Participate on Continuous Improvement Teams
• Train and mentor other team members
• Write, revise and review pertinent documentation as appropriate
• Troubleshoot process problems and respond to process alarms
• Assist with process/equipment validation and data analysis
• Work with other groups such as maintenance/metrology and calibration to ensure preventative maintenance completion
• Required to maintain attendance in accordance with the Bloomington Attendance Policy
• Scheduled weekend overtime will be required

Work Environment: 

Classified pharmaceutical environment wearing required gowning. Must be able to work safely with materials required to produce pharmaceutical products, including chemicals, compounds, glassware and sanitization solutions.  Must be able to occasionally (1-33% of the time) work in a confined/clustered work space.

Desirable qualifications: