Summer Internship – CAPEX/Expansion Project Engineering

Job Description

Simtra BioPharma Solutions (Simtra) is seeking highly motivated undergraduate and graduate students for our Summer Internship Program within the CAPEX (Capital Expenditures)/Expansion Project Engineering Team. This role offers an immersive experience for students eager to contribute to real-world projects in the biopharmaceutical industry.

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About Simtra BioPharma Solutions

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization (CDMO), 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.

The Role

Simtra is seeking highly motivated undergraduate and graduate students for our Summer Internship Program. We look for diverse students with inquisitive minds and the desire to challenge themselves. Our interns work closely with industry professionals and learn quickly how to problem solve 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: CAPEX/Expansion Project Engineering Team

The CAPEX (Capital Expenditures)/Expansion Project 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.

Responsibilities/Projects

The intern will assist in leading and managing facility expansion projects, including:

• Developing and maintaining project tracker.
• Developing SOP changes.
• Supporting construction quality activities.
• Supporting turn-over package requirements.
• Supporting all validation activities (writing protocols).
• Coordinating internal stakeholders and external contractors.
• Troubleshooting and resolving technical challenges related to project implementation.
• Developing upcoming year’s Engineering Capital Plan and ensuring submitted projects contain a defined scope, budget, and schedule to sustain and support Site growth.
• Interacting with all functions and levels of management, ensuring effective, ongoing communications across teams and stakeholders.
• Assisting Project Managers/Engineers on project deliverables.
• Participating in all collaborations with external engineering firms in feasibility assessments, concept design, basic design, and detail design.
• Participating in technical review of all external engineering design reviews.
• Assisting with work orders, preventative maintenance plans, P&ID redlines, spare parts management, among other activities related to project documentation.
• Assisting with project CQV (commissioning, qualification, and validation) activities.

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).
• Proficient in project management tools (MS Project, Primavera, JIRA, etc.).
• Experience and the ability to use enterprise software (examples include: JDE, Microsoft Dynamics, BPLM, Veeva, Trackwise, etc.).

Onsite Campus Amenities

• Workout Facility
• Cafeteria
• Credit Union

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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