Position Summary
The Sterility Assurance Program Manager serves as the technical subject matter expert and strategic owner of the site's Contamination Control Strategy (CCS) and sterility assurance systems within a GMP-regulated manufacturing environment. This role will be responsible for building the sterility program for products manufactured at the facility. The candidate will be responsible for driving continuous improvement, oversight, and operational execution of aseptic processing, sterilization, and environmental monitoring programs, ensuring total compliance with evolving global regulations (including EU GMP Annex 1 and FDA requirements).
Key Responsibilities
Contamination Control and Program Strategy:
•Build, maintain, and continuously improve the site's CCS, sterility assurance program, including policies, procedures, and related documentation.
Validation and Aseptic Governance:
•Provide technical leadership for completion of validation and monitoring of sterilization processes, including aseptic processing, sterilizer cycles, barrier systems, bioburden/endotoxin testing strategies, and environmental controls.
•Manage aseptic process validations/simulations, including protocol development, data review, and final report generation. Ensure compliance with regulatory requirements and internal standards.
Cross-functional Quality Leadership:
•Lead deviation investigations, root cause analyses, and CAPAs related to sterility failures or environmental monitoring excursions; drive risk management tools (FMEA, HACCP).
•Collaborate with Quality Assurance, Manufacturing, Microbiology, and Engineering departments to drive continuous improvement initiatives.
•Monitor sterility assurance metrics and prepare reports for senior management.
Regulatory and Audit Readiness:
•Ensure compliance with applicable regulations and standards (e.g., FDA, EMA, USP, ISO), with specific knowledge and application of EU GMP Annex 1 guidelines.
•Prepare detailed technical reports and documentation related to sterility assurance activities for internal review and regulatory submissions.
•Support regulatory inspections and audits, acting as the subject matter expert for sterility assurance.
Training and Compliance:
•Ensure compliance with qualification and ongoing training of manufacturing personnel in aseptic techniques, contamination control, and sterility requirements.
•Conduct training and provide guidance on sterility assurance principles and best practices.
Qualifications
Education and Experience:
•Bachelor's degree in Microbiology, Biology, Biochemistry, Chemical Engineering, or a related scientific/engineering discipline. Master's or advanced degree preferred.
•Minimum of 6 to 8 years of progressive experience in sterility assurance, microbiology, or validation within a sterile pharmaceuticals or biologics GMP manufacturing environment.
•Certifications (Preferred): ASQ Certified Pharmaceutical GMP Professional (CPGP), Certified Quality Engineer (CQE), or Certified Microbiologist.
Knowledge, Skills, and Abilities:
•Regulatory & Compliance Mastery: In-depth knowledge of and practical experience applying EU GMP Annex 1, FDA cGMP, USP (e.g., <71>, <85>), ISO 13408, and ISO 14644 standards.
•Validation Expertise: Proven track record in planning, executing, and reporting on aseptic process simulations (media fills), terminal sterilization cycles, and cleanroom qualification.
•Contamination Control & Investigation: Strong capability in leading root cause analysis (RCA), CAPA management, and microbial deviation investigations related to environmental monitoring (EM) excursions.
•Excellent analytical, problem-solving, and project management skills.
•Strong communication and interpersonal skills.
•Ability to influence and drive changes in a complex, regulated environment.
•Experience with Sterile Dosage Forms manufacturing.
Working Conditions
•Onsite work required in GMP manufacturing environments, laboratories, and controlled production areas.
•Exposure to biologics, chemicals, and standard bioprocessing equipment.
•Work may require standing, walking, or operating equipment for extended periods.
•May require occasional early hours or weekends based on production schedules.
Physical Requirements
•Ability to lift and move items up to 40–50 lbs.
•Ability to wear PPE required for clean room operations.
•Ability to maneuver equipment such as carts, cylinders, or supplies as needed.
•Extended periods of standing, walking, or working at production equipment and clean room environment.
•Extended periods sitting and performing computer work.
Pay Range
$115,900.00 - $190,450.00
Why Join Bio-Techne
•Competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield.
•401k plans, employee stock purchase plan (ESPP), Health Savings Account (HSA), Flexible Spending Account (FSA), and Dependent Care FSA.
•Career development through mentorship, promotional opportunities, training and development, tuition reimbursement, internship programs, and more.
•Employee resource groups, volunteer paid time off, employee events, and charity drives.
•Accrued leave policy with paid holidays, paid time off, and paid parental leave.
•A culture of empowerment and innovation.
This position requires work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States (e.g., H1-B visa, F-1 visa (OPT), TN visa or any other non-immigrant work status).
