What are the responsibilities and job description for the 2026 Spring Co-Op - Validation/CQV (Engineering) position at simtrabps?
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.
The Role:
Simtra is seeking highly motivated undergraduate students for our inaugural Spring Co-Op 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:
The Validation Engineering team focuses on ensuring that the equipment, facilities, and systems comply with regulatory standards by developing, executing, and maintaining protocols for installation, operations, and performance.
Responsibilities/Projects:
The Validation Engineering Co-Op will support the qualification and validation of equipment, facilities, and utilities used in aseptic pharmaceutical manufacturing. This role provides hands-on experience in a GMP (Good Manufacturing Practice) environment, offering exposure to project execution, technical writing, data analysis, and cross-functional teamwork.
Key activities will include:
- Assisting in developing and executing validation protocols (IQ/OQ)
- Support data collection, analysis, and report preparation to demonstrate compliance with regulatory and company standards
- Participate in deviation investigations and corrective/preventive action (CAPA) processes
- Review and update standard operating procedures (SOPs) and validation documentation
- Support change control activities
- Gain exposure to aseptic manufacturing processes and sterile fill-finish systems
Required Qualifications:
- Pursuing a BS degree in Engineering (Mechanical, Chemical, Industrial, Biomedical, or Electrical)
- Enrolled in a co-op program
- Potential ability to complete 2 co-op rotations (Spring/Summer) [preferred, not mandatory]
- Advanced proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)
- Knowledge and/or experience using VIZIO
- Excellent organizational, oral and written communication skills
- Strong attention to detail including the ability to accomplish a task while demonstrating a thorough concern for all the areas involved.
- Experience with technical writing
- Strong interpersonal skills and the ability to work well with others in a proactive, positive and constructive manner
- Highly motivated, self-driven individual with passion working within pharmaceutical industry
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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