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 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/

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:

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/

• Coordinate MCN and ECN workflows from initiation through implementation, tracking changes through defined gates and ensuring timely completion of cross-functional actions.
• Prepare and distribute Change Control Board (CCB) meeting packages, agendas, and action item logs.
• Maintain the change control log and tracking tools (Smartsheet), ensuring data accuracy and status visibility for all stakeholders.
• Follow up with cross-functional team members (engineering, quality, manufacturing, supply chain, maintenance) to drive action closure.
• Support trial planning and execution for manufacturing changes, including readiness checklists, parts availability, and data capture.
• Coordinate implementation follow-through on change-driven actions including BOM updates, work order modifications, and Work Instruction revisions.
• Facilitate review meetings, document decisions and approvals, and track open items to closure within agreed timelines.
• Escalate systemic or high-risk issues to the appropriate engineering, quality, or program management lead.

• Assist area TPMs with smaller launch activities including milestone tracking, readiness gate preparation, and issue resolution.
• Support launch wall updates and reporting for assigned activities.
• Coordinate documentation updates for launch-related changes including Work Instructions, PFMEA, and Control Plans.

• Ensure all change and launch documentation meets plant standards for completeness, accuracy, and revision control.
• Communicate change status, risks, and escalations to the Change Management Lead and PM team.
• Maintain organized records of change history, dispositions, approvals, and supporting documentation.
• Support ERP transactions in NetSuite related to change activity as needed.

• Bachelor’s degree in Engineering, Manufacturing, Industrial Engineering, Business Administration, or related field.
• 8+ years of related experience with a Bachelor’s degree, 6 years with a Master’s degree, or 3 years with a PhD, or equivalent professional experience.
• Experience in automotive or high-volume manufacturing environments, preferably in change control, non-conformance management, launch coordination, or program management support roles.

• Strong organizational skills with the ability to manage multiple concurrent changes and priorities.
• Understanding of manufacturing change control processes (ECR/ECN), non-conformance/deviation workflows, and manufacturing documentation (Work Instructions, PFMEA, Control Plans).
• Proficiency with Smartsheet, Excel, and project tracking tools.
• Working knowledge of ERP systems (NetSuite) for inventory, work order, and change-related transactions.
• Strong cross-functional communication skills and ability to drive accountability without direct authority.
• Detail-oriented with a focus on process discipline and follow-through.
• Familiarity with PLM systems (Windchill, Teamcenter) a plus.
• Familiarity with quality management systems (IATF 16949, ISO 9001) preferred.
• PMP, Six Sigma, or Lean certifications helpful.

The Clinical Material Coordinator and SAP Process Owner is responsible for the business processes associated with inputting molecules into SAP, as well as movement of materials within internal clinical trial manufacturing sites and manufacturing at external collaboration partners. This includes the logistics associated with drug substance and drug product shipping, sample shipment and storage and raw material coordination. This role will support manufacturing across the Product Research and Development (PRD) Organization. The Material Coordinator will represent the Clinical Manufacturing organizations to streamline communications with Clinical Supply and Delivery and the supporting QA teams.

Clinical Material Coordinator Responsibilities:

• Establish SAP and Business processes to support material movements, both physically and within SAP and Quality Systems, for all PRD organizations.
• Maintain SAP data related to orders in support of the organization, this includes:
  • Establish new materials and purchasing information aligned with sourcing decisions
  • Create new vendor and customer numbers as needed
  • Establish Source List for triangulated sales products as needed
  • Accountable for MRP (Manufacturing Resource Planning) actions from the point of demand entry, purchase order creation through successful incoming receipt; reconciling any discrepancies be-tween goods receipt and contract partner invoice; completes business work center items to ensure all work is done and batch release
• Manage shipment of drug substance and samples to contract partners, warehouse, and testing facilities
• Own and optimize drug substance release huddle with development and QA to align on priorities, actions and approvals
• Communicate and work with Manufacturing Plant Planners on scheduling constraints and issues that require an adjustment to the plan in regard to drug substance availability and delivery, including drug substance representative at huddles
• Build strong relationships with development organizations through routine touch points
• Monitors delivery due dates and notify development or commercial teams when shipment of drug sub-stance is needed based on supply plan; ensures necessary import approvals are in place prior to shipment execution; creates outbound delivery if needed and performs goods issue in SAP as necessary
• Accountable for document exchange with the contract partner (e.g., ticket copies, CT packet, CoA's and other supporting documents regarding raw materials and components) and upload into internal system
• Coordinate activities and communicate timing on incoming and outgoing shipment schedules
• Upon completion of manufacturing order, performs SAP goods receipt; reconciles any discrepancies be-tween goods receipt and contract partner invoice; completes business work center items to ensure all work is complete
• Conducts periodic inventory reconciliations
• GMP Compliance
• Must be knowledgeable on how to apply GMPs in a clinical trial environment. Authors, reviews, and follow procedures applicable to the Clinical Trial business. In addition, individual training plans must be kept up to date
• Quality Assurance
  • Authors appropriate deviations (e.g., L1 temperature excursions, shipping, samples)
  • Participates in departmental site self-assessments and relevant audits

Requirements:

Skill Set:

• Excellent oral and written communication skills with the ability to interact well in a team environment
• Ability to develop/manage relationships with contract partners
• Ability to collaborate with partners around the world
• Initiative and ability to handle multiple projects in an independent fashion
• Excellent organization and self-management skills
• High initiative, flexible and positive attitude
• Ability to respond to changing priorities and short lead times

Technical:

• Experience with SAP
• Experience in managing inventory/supplies or complex supply chains
• Knowledge of clinical trial manufacturing operations
• Ability to use and apply multiple computer applications
• Ability to proactively identify problems and work toward a solution
• Minimum 1 year in a GMP environment

Education:

• Bachelor’s degree, preferably in health care or sciences related field or 10+ years’ work experience in supply chain or operations

Onsite job requirement in Indianapolis, IN.

About the team:

Formic’s Sales Team drives adoption of automation across SMB and mid-market manufacturing. The team partners closely with Engineering, Solutions, and Customer teams to educate manufacturers, develop territory strategies, and build pipeline through disciplined outreach and consultative selling.

About the role: 

As an Automation Sales Manager, you will be responsible for revenue growth and market expansion within your territory. You will develop and execute a strategic territory plan, build deep knowledge of the regional manufacturing landscape, and establish trusted relationships with manufacturers, integrators, and strategic partners.

You will work directly with customers to evaluate automation opportunities, define project requirements, and collaborate with Engineering and Solutions teams to develop system concepts. You will also lead commercial negotiations and own the full sales cycle from initial engagement through contract execution.

This is an individual contributor role responsible for driving territory growth, building a strong pipeline, and delivering consistent revenue performance.

In this role you will:

• Own and execute a regional territory strategy to drive pipeline growth and revenue attainment
• Generate and qualify new business opportunities within SMB and mid-market manufacturing accounts
• Lead consultative discovery conversations and on-site meetings with manufacturing decision makers
• Develop tailored automation solutions in partnership with Solutions and Engineering teams
• Advance opportunities through the full sales cycle from prospecting to contract execution
• Build and maintain executive-level relationships across plant, operations, and ownership stakeholders
• Represent Formic at industry events and trade shows to expand regional market presence
• Maintain accurate CRM data, pipeline visibility, and forecast accuracy
• Analyze regional manufacturing trends, competitor activity, and buyer dynamics to refine territory strategy

What makes you a great fit:

• Proven success in full-cycle B2B sales with consistent revenue attainment
• Experience owning and growing a geographic territory independently
• Demonstrated ability to proactively build pipeline in new or underpenetrated markets
• Strong understanding of manufacturing operations and industrial buying processes
• Ability to navigate multi-stakeholder buying committees and technical decision makers
• Analytical mindset with the ability to quantify value and clearly communicate ROI
• Proficiency with Salesforce or comparable CRM systems
• Willingness and ability to travel up to approximately 75 percent within the assigned region
• Comfort operating in a fast-growth environment with evolving processes and priorities