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 co-ops will 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 Process Engineering teams ensure the sterile injectable lines run the way the business, the client, and the regulation agencies need them to run - reliable, efficient, and compliant. This team supports the day-to-day aseptic formulation, filling, and finishing for vials, syringes, and lyophilization products at the Bloomington facility.
Responsibilities/Projects:
The Process Engineering Co-Op will support specific equipment lines. They will focus on supporting the engineering/maintenance/manufacturing teams in driving process optimization excellence in a sterile injectable manufacturing facility. They work on equipment qualification, data analysis, troubleshooting, and continuous improvement initiatives.
Key activities will include:
- Monitor throughput, yields, downtime, rejections to develop continuous improvement and suggest process optimization
- Ensure process line configuration, set-ups, and parameters match validation
- Support projects to: reduce changeover time, improve fill time, smooth formulation steps, etc. and write technical documentations (change controls, work orders, SOP updates)
- Investigate out of specification, root cause, and deviations and provide corrective/preventive actions
Required Qualifications
Onsite Campus Amenities:
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.
Data Privacy
To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy: https://simtra.com/privacy-policy/