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.

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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:
The Technical Services (Risk Management) team focuses on identifying, assessing, and mitigating risks associated with pharmaceutical manufacturing, quality, and compliance. They develop risk management strategies for production and supply chain.

Responsibilities/Projects:
The intern will be assigned to a project that supports a Process Validation Risk Management associate to assist in a PFMEA that will assess personnel, facility, training, raw materials, process, cleaning & sanitization risk for the qualified areas.

The intern will have hands-on experience in risk assessment methodologies, technical services support, regulatory compliance, and continuous improvement initiatives. They will collaborate with cross-functional teams in Quality Assurance, Manufacturing, Engineering, and Regulatory Affairs to support risk management and technical services projects.

Required Qualifications:

• Pursuing a BS degree in Life Sciences, Risk Management, or a related field
• Intermediate proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) for data analysis and reporting
• Knowledge of risk management principles, regulatory requirements, and quality management systems
• Experience with risk assessment tools (FMEA, Fault Tree Analysis)
• Excellent organization, 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.
• Strong analytical and problem-solving skills
• 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

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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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