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/

Job Summary:

We are seeking a Risk Management Project Engineer to support the IDM Risk Management Turbo AC team. This role will support creation and continuous improvement of risk management deliverables aligned with ISO 14971 in the Turbo AC software, assist with migration of FMEAs from existing Software, and serve as an SME of the Turbo AC Software System.

You will play a key role in collaborating across engineering, manufacturing, quality, and human factors teams to ensure the setup and structure of the FMEAs are accurate to Client SOPs and ISO 14971.

Key Responsibilities:

• Support the development and deployment of risk management deliverables in alignment with ISO 14971
• Serve as subject matter expert for the Turbo AC Software System
• Facilitate and author the migration activities of FMEAs from an existing Software System into Turbo AC
• Conduct working sessions to guide teams on how to use the Turbo AC Software System
• Document bugs and tangible upgrade features to share with the Turbo AC Development team
• Creating and Running test scripts to support Turbo AC upgrade Validation
• Collaborate with cross-functional teams including Systems Engineering, Manufacturing, Human Factors, and Mechanical Design
• Create/update standard operating procedures

Qualifications:

• Bachelor’s degree in engineering, biomedical, systems, or related field
• 1-3 years of experience in medical device development or risk management
• Knowledge of ISO 14971
• Experience creating and reviewing FMEAs and other risk tools
• Strong organizational and communication skills, especially in cross-functional settings
• Proficiency with Microsoft Office tools such as Excel, PowerPoint
• Onsite job requirement in Indianapolis, IN

Nice to Have Skills:

• Experience with risk management tools like TurboAC or QMSpace
• Familiarity with the design control processes under FDA and EU MDR frameworks
• Experience with Change Control Trackwise or Veeva OneQMS

Job Summary:

We are seeking a Risk Management Engineer to support the IDM Risk Management Turbo AC team. This role will support creation and continuous improvement of risk management deliverables aligned with ISO 14971 in the Turbo AC software, assist with migration of FMEAs from existing Software, and serve as an SME of the Turbo AC Software System.

You will play a key role in collaborating across engineering, manufacturing, quality, and human factors teams to ensure the setup and structure of the FMEAs are accurate to Client SOPs and ISO 14971.

Key Responsibilities:

• Support the development and deployment of risk management deliverables in alignment with ISO 14971
• Serve as subject matter expert for the Turbo AC Software System
• Facilitate and author the migration activities of FMEAs from an existing Software System into Turbo AC
• Conduct working sessions to guide teams on how to use the Turbo AC Software System
• Document bugs and tangible upgrade features to share with the Turbo AC Development team
• Creating and Running test scripts to support Turbo AC upgrade Validation
• Collaborate with cross-functional teams including Systems Engineering, Manufacturing, Human Factors, and Mechanical Design
• Create/update standard operating procedures

Qualifications:

• Bachelor’s degree in engineering, biomedical, systems, or related field
• 3-5 years of experience in medical device development or risk management
• Knowledge of ISO 14971
• Experience creating and reviewing FMEAs and other risk tools
• Strong organizational and communication skills, especially in cross-functional settings
• Proficiency with Microsoft Office tools such as Excel, PowerPoint

Nice to Have Skills:

• Experience with risk management tools like TurboAC or QMSpace
• Familiarity with the design control processes under FDA and EU MDR frameworks
• Experience with Change Control Trackwise or Veeva OneQMS

Responsibilities:

Entry level CQV Engineer position in the Pharma industry. Client will train the resource on Deviation Investigation.

Requirements

• Deviation investigation remediation experience is a plus but is not necessary.
• Undergraduate Engineering/STEM degree preferred (mechanical, chemical, biomedical, etc.).
• 0-3 years experience. Some Pharma experience preferred but not absolutely required. New college grads with internship experience encouraged to apply
• Proficiency using PC and Microsoft Office tools.
• Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms.
• Ability to work as part of a team.
• Strong problem-solving and critical thinking skills.
• Excellent organizational and time management skills.
• Strong attention to detail
• Strong interpersonal skills and clear communication capabilities.
• Experience with and tolerance for high levels of challenge and change.