2026 Fall Co-Op Project Engineer
About The Position
Simtra BioPharma Solutions is seeking highly motivated undergraduate students for their 2026 Fall Co-Op Program. This program is designed for diverse students with inquisitive minds and the desire to challenge themselves. Co-Ops will work closely with industry professionals, learn to solve problems on real-world projects contributing to clinical research and manufacturing processes. The program includes on-the-job experience, learning sessions with top leadership, site visits, and social events. The CAPEX (Capital Expenditures) Project Expansion Engineering Team is responsible for developing and maintaining the long-term CAPEX roadmap, identifying major facility expansions, managing equipment upgrades, and supporting process improvement investments. They conduct feasibility studies and business case development, prioritize projects, and create/implement engineering and design specifications, while managing project execution and oversight.
Requirements
- 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.
- Ability to read mechanical, electrical, and P&ID drawings.
- Advanced proficiency in Microsoft Office Suite (Word, Excel, and Outlook).
Responsibilities
- Assist in leading and managing facility expansion projects, including developing and maintaining project trackers.
- Develop SOP changes.
- Support construction quality activities.
- Support turnover package requirements.
- Support all validation activities, including writing protocols.
- Coordinate internal stakeholders and external contractors.
- Troubleshoot and resolve technical challenges related to project implementation.
- Support startup, commissioning, and qualification of new equipment (e.g., vial filling line, lyophilizers, autoclaves, formulation, WFI, pure steam, heating hot water).
- Review and author internal validation protocols, reports, and traceability matrices.
- Review vendor documentation packages, including drawings, P&IDs, software, manuals, and validation deliverables.
- Execute validation protocols (IQ and OQ) for filling line equipment, process equipment, and utilities required to support vial filling manufacturing.
- Resolve technical and compliance gaps between vendor equipment and cGMP standards.
- Prepare and maintain documentation, including standard operating procedures, equipment manuals, and maintenance records.
- Assist Project Managers/Engineers on project deliverables.
- Participate in collaborations with external engineering firms in feasibility assessments, concept design, basic design, and detailed design.
- Assist with creating work orders, preventative maintenance plans, P&ID redlines, spare parts management, and other project documentation activities.
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
- Paid Holidays
- Paid Time Off
- Paid Parental Leave
- Adoption Reimbursement Program
- Education Assistance Program
- Employee Assistance Program
- Community and Volunteer Service Program
- Employee Ownership Plan
- Short and Long-Term Disability Insurance
- Voluntary Insurance Benefits
- Vision Coverage
- Accident Critical Illness Insurance
- Hospital Indemnity Insurance
- Identity Theft Protection
- Legal Assistance
- Workout Facility
- Cafeteria
- Credit Union
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What This Job Offers
Job Type
Full-time
Career Level
Intern
Education Level
Associate degree
