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Bloomington, Indiana, United States
Onsite
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:
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 processes. In 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, you’ll be eligible for[1]:
[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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