2026 Summer Internship - Risk Management (Technical Services)
Company: Simtra BioPharma Solutions
Location: Bloomington
Posted on: April 1, 2026
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Job Description:
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 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
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/
Keywords: Simtra BioPharma Solutions, Louisville , 2026 Summer Internship - Risk Management (Technical Services), Science, Research & Development , Bloomington, Kentucky