{"id":1261197,"url":"https://alion.io/job/bio-techne-sterility-assurance-program-manager","title":"Sterility Assurance Program Manager","company":{"id":7354,"name":"Bio-Techne","domain":"bio-techne.com","url":"https://alion.io/company/bio-techne","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":80,"open_postings":10,"ghost_share":0,"stale_share":0.6,"repost_share":0,"time_to_fill_p50_days":60,"computed_at":"2026-10-28T05:59:10Z"}},"role":"Management","role_family":"Management","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Saint Paul, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":78100,"max":128500,"currency":"USD","period":"year","gross":null,"usd_annual":128500},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":true,"relocation_package":false,"has_equity":true,"technologies":[{"name":"CAPA","optional":false},{"name":"Mandiant capa","optional":false}],"status":"live","first_seen_at":"2026-08-18T00:00:00Z","employer_posted_date":"2026-08-18","last_verified_at":"2026-10-28T03:26:37Z","board_verified":true,"closed_at":null,"days_open":71,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":71},"description":"By joining Bio-Techne, you’ll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide.\nPay Range:\n$78,100.00 - $128,500.00Position Summary:\nThe Sterility Assurance Program Manager is responsible for the development, implementation, oversight, and continuous improvement of the sterility assurance program within a GMP-regulated manufacturing environment. This role ensures that all processes related to aseptic processing, sterilization, and contamination control meet regulatory requirements and internal quality standards to guarantee product sterility.\nKey Responsibilities:\nOwn and manage the sterility assurance program, including policies, procedures, and related documentation.\n\nDevelop, implement, and maintain sterility assurance programs including sterilization validations, bioburden testing, endotoxin testing, and contamination control strategies.\n\nLead cross-functional teams to assess sterility risks and develop mitigation plans.\n\nOversee validation and monitoring of sterilization processes including aseptic processing, sterilizer cycles, and environmental controls.\n\nOwn the planning, execution, and approval of aseptic process simulations (media fills) ensuring compliance with regulatory requirements and internal standards.\n\nComplete aseptic process validations, including protocol development, execution, data review, and final report generation.\n\nEnsure qualification and ongoing training of manufacturing personnel in aseptic techniques, contamination control, and sterility requirements.\n\nPrepare detailed technical reports and documentation related to sterility assurance activities for internal review and regulatory submissions.\n\nEnsure compliance with applicable regulations and standards (e.g., FDA, EMA, USP, ISO), with specific knowledge and application of EU GMP Annex 1 guidelines.\n\nCollaborate with Quality Assurance, Manufacturing, Microbiology, and Engineering departments to drive continuous improvement initiatives.\n\nManage deviation investigations, root cause analysis, and CAPA related to sterility assurance issues.\n\nConduct training and provide guidance on sterility assurance principles and best practices.\n\nSupport regulatory inspections and audits, acting as the subject matter expert for sterility assurance.\n\nMonitor sterility assurance metrics and prepare reports for senior management.\n\nStay updated with advances in sterility assurance technologies, regulatory changes, and industry best practices including Annex 1 revisions.\n\nQualifications:\nStrong knowledge of aseptic processing, sterilization methods, contamination control, microbiological testing, aseptic process simulations (media fills), and process validations.\n\nProven experience in the qualification and training of manufacturing personnel in aseptic techniques and sterility assurance requirements.\n\nExperience owning, executing, and reporting on aseptic process validations in compliance with regulatory standards.\n\nIn-depth knowledge of EU GMP Annex 1 and the ability to apply its requirements effectively in a manufacturing environment.\n\nFamiliarity with regulatory requirements including FDA cGMP, EMA, USP , ISO 13485, and related standards.\n\nExperience with risk management methodologies and tools (e.g., FMEA, HACCP).\n\nProven experience in managing sterility assurance programs and leading cross-functional initiatives.\n\nExcellent analytical, problem-solving, and project management skills.\n\nStrong communication and interpersonal skills.\n\nAbility to influence and drive changes in a complex, regulated environment.\n\nDetail-oriented with strong documentation and record-keeping skills.\n\nEducation and Experience:\nBachelor’s degree in biology, Microbiology, or Engineering. Advanced degree preferred.\n\nMinimum of 5 years of experience in sterility assurance, quality assurance, or a related role within a GMP manufacturing environment.\n\nKnowledge, Skills, and Abilities:\nStrong knowledge of aseptic processing, sterilization methods, contamination control, microbiological testing.\n\nExperience with aseptic process simulations (media fills) including planning, execution, and approval.\n\nProven experience in completing aseptic process validations and report generation.\n\nAbility to qualify and train manufacturing personnel in aseptic techniques and sterility assurance standards.\n\nStrong analytical and problem-solving skills with attention to detail.\n\nGood communication skills, able to clearly document and report findings.\n\nEffective project and time management skills.\n\nAbility to work collaboratively across multiple departments and influence stakeholders.\n\nPreferred Skills:\nExperience with sterile dosage forms manufacturing.\n\nProficiency with electronic quality management systems (eQMS).\n\nAdvanced degree in relevant scientific discipline.\n\nWorking Conditions:\nOnsite work required in GMP manufacturing environments, laboratories, and controlled production areas.\n\nExposure to biologics, chemicals, and standard bioprocessing equipment.\n\nWork may require standing, walking, or operating equipment for extended periods.\n\nMay require occasional early hours or weekends based on production schedules.\n\nPhysical Requirements:\nAbility to lift and move items up to 40-50 lbs.\n\nAbility to wear PPE required for clean room operations.\n\nAbility to maneuver equipment such as carts, cylinders, or supplies as needed.\n\nExtended periods of standing, walking, or working at production equipment and clean room environment.\n\nExtended periods sitting and performing computer work.\n\nWhy Join Bio-Techne:\nWe offer competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield.\n\nWe invest in our employees’ financial futures through 401k plans, an employee stock purchase plan (ESPP), Health Saving Account (HSA), Flexible Spending Account (FSA), and Dependent Care FSA.\n\nWe empower our employees develop their careers through mentorship, promotional opportunities, training and development, tuition reimbursement, internship programs, and more.\n\nWe offer employee resource groups, volunteer paid time off, employee events, and charity drives to build a culture of caring and belonging.\n\nWe offer an accrued leave policy with paid holidays, paid time off, and paid parental leave.\n\nWe foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.\n\nBio-Techne is an E-Verify Employer in the United States.\nAll qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.\nTo protect the interests of all, Bio-Techne will not accept unsolicited resumes from any source other than a candidate application. Any unsolicited resumes sent to Bio-Techne will be considered Bio-Techne property.\nThis 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). 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