Sterility Assurance Specialist
Location: Bloomington, Indiana
Job Type: Full-time
About Novo Nordisk
For more than 100 years, Novo Nordisk has been at the forefront of diabetes care. Today, we continue to drive innovation in healthcare, focusing on solutions to defeat chronic diseases and improve long-term health outcomes.
Our Bloomington, Indiana site is a state-of-the-art facility with an integrated model spanning process development, formulation, clinical and commercial biomanufacturing, drug product fill/finish, and packaging. Here, talented teams collaborate with innovators to deliver high-quality medicines to patients worldwide.
At Novo Nordisk, you’ll find the opportunity, resources, and mentorship to build a meaningful career while making a difference.
About the Department
The Sterility Assurance Department ensures compliance with FDA, regulatory agency requirements, and internal quality systems. The team safeguards systems, processes, and practices that are critical for manufacturing safe, high-quality drug products.
Departmental Groups
Quality Assurance Systems
Manages deviations, CAPAs, change controls, document control, supplier quality, raw material disposition, training, equipment calibration, and validation oversight.
Quality Assurance Operations
Oversees manufacturing, process technology transfer, batch record review/approval, on-the-floor support, product disposition, and shipping.
Quality & Compliance
Leads internal/client audits, regulatory inspections, compliance support initiatives, and validation activities.
What We Offer
Competitive pay and annual performance bonus
14 paid holidays and generous PTO
Health, dental, and vision insurance (effective day one)
8% guaranteed 401(k) contribution + company match
Family-focused benefits (14 weeks paid parental leave & 6 weeks family medical leave)
Free access to Novo Nordisk-marketed pharmaceuticals
Tuition assistance
Life & disability insurance
Employee referral awards
Role Summary
As a Sterility Assurance Specialist, you will oversee, document, and track the sterility assurance program for a world-class pharmaceutical facility. This role provides the opportunity to work cross-functionally, ensuring contamination control, aseptic compliance, and regulatory adherence.
Key Responsibilities
Observe and coach aseptic behaviors during production and Aseptic Process Simulations (APS) / media fills
Advise on sterility assurance, microbiological protocols, and procedures
Support leadership in implementing quality systems and ensuring compliance
Author and revise departmental documents to meet site, global, and regulatory standards
Propose corrective and preventive actions (CAPAs) to enhance contamination controls
Maintain traceability of observations and communicate findings to management
Collaborate with team members on Contamination Control Strategy and sterility assurance programs
Drive improvements in cleanroom practices to minimize contamination risks
Qualifications
Bachelor’s degree in Science (Microbiology preferred)
Minimum 5 years’ experience in aseptic processing within pharmaceutical/biotech manufacturing
Strong knowledge of regulatory standards for sterile manufacturing and aseptic processing
Experience with regulatory inspections and audits
Physical & Work Requirements
Ability to sit, stand, walk, read, and use a computer for extended periods
Occasional bending, kneeling, or lifting (up to 50 lbs)
Must complete gowning certification and operate in cleanroom environments
Ability to work 8–10 hours in controlled conditions (HVAC-regulated areas)
Compliance with EHS (Environment, Health & Safety) responsibilities
Our Commitment to Diversity & Inclusion
At Novo Nordisk, we aspire not just to be the best company in the world, but the best company for the world. We embrace diversity of backgrounds, perspectives, and cultures to build an inclusive workplace that reflects the communities we serve.
We are an equal opportunity employer. Qualified applicants will be considered without regard to race, ethnicity, religion, sex, gender identity, sexual orientation, disability, veteran status, or other protected characteristics.
If you require accommodation during the application process, please contact us at 1-855-411-5290.
👉 Join Team Novo Nordisk and help us make what matters—life-changing medicines for millions of patients worldwide.
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