2026 Fall Co-Op Project Engineer

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 teamsso we can solve problems in new ways.

Make it RIGHT We hold ourselves to a high standard of excellencefulfilling 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:

Simtra is seeking highly motivated undergraduate students for our 2026 Fall Co-Op Program. We look for diverse students with inquisitive minds and the desire to challenge themselves. Our Co-Ops work closely with industry professionals and learn quickly how to solve problems on real-world projects that contribute to clinical research and manufacturing addition to on-the-job experience we offer learning sessions with top leadership site visits to local projects and social events

The Opportunity:

The CAPEX (Capital Expenditures) Project Expansion Engineering Team develops and maintains the long-term CAPEX roadmap including but not limited to - identifying major facility expansions managing major equipment upgrades and supporting process improvement investments. They perform feasibility studies and business case development for capital projects while prioritizing projects using multi-criteria analysis. Other responsibilities include creating and implementing engineering and design specifications and managing project execution and oversight.

The responsibilities:

The CAPEX Project Expansion Engineering team focuses on the planning execution and overseeing of capital expenditure projects. They ensure that facility expansions equipment installations and infrastructure upgrades are completed on time within budget and in compliance with regulatory (FDA cGMP etc.) standards. The co-op will assist in leading and managing facility expansion projects - including developing and maintaining project tracker developing SOP changes supporting construction quality activities supporting turnover package requirements and supporting all validation activities (writing protocols). They will coordinate internal stakeholders and external contractors. The co-op will also troubleshoot and resolve technical challenges related to project implementation.

Supports startup commissioning and qualification of new equipment including vial filling line lyophilizers autoclaves formulation WFI pure steam heating hot water etc.
Reviews and author internal validation protocols reports and traceability matrices
Reviews vendor documentation packages including drawings P&IDs software manuals and validation deliverables
Executes validation protocols (IQ and OQ) for filling line equipment process equipment and utilities required to support vial filling manufacturing
Resolves technical and compliance gaps between vendor equipment and cGMP standards
Prepares and maintains documentation including standard operating procedures equipment manuals and maintenance records
Assists Project Managers/Engineers on project deliverables
Participates in collaborations with external engineering firms in feasibility assessments concept design basic design and detailed design
Assists with creating work orders preventative maintenance plans P&ID redlines spare parts management among other activities related to project documentation

Required Qualifications:

Pursuing a BS or MS degree in Engineering (Chemical Mechanical Electrical Packaging Pharmaceutical Biomedical) or a related technical field
Strong oral and written communication skills
Must be able to read mechanical electrical and P&ID drawings
Advanced proficiency in Microsoft Office Suite (Word Excel and Outlook)

In return youll be eligible for1:

• 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.

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