Sterility Assurance Manager
Thermo Fisher Scientific
Summary
Manager Sterility Assurance is responsible for establishing, maintaining, and continuously improving the site's strategy at a sterile fill / finish manufacturing facility. He/she needs to drive compliance with regulatory requirements (FDA, EMA, PIC/S, Annex 1) and sterility assurance initiatives, microbiological oversight collaboration, and aseptic assurance across the manufacturing site. This role serves as the SME (subject matter expert) for aseptic practices, maintenance of aseptic observation program data metrics, and the overall contamination control strategy (CCS).
Job description
A Day in the Life
- Promote understanding of and compliance to aseptic processes and related regulations such as EU Annex 1 & the FDA's aseptic processing guide.
- Conduct regular GEMBA style assessments of the aseptic process on site to assess compliance, identify improvements and provide real time coaching to aseptic staff
- Define, oversee and where necessary improve the EM & Contamination Control programs.
- Assist with microbiological and sterility risk assessments for changes, deviations, and CAPAs involving aseptic operations.
- Serve as the SME during regulatory inspections and audits regarding aseptic processing, and contamination control.
- Present aseptic observation program data to site and executive leadership in management review forums, including trending and improvements made
- Collaborates with manufacturing, microbiology, and QC as the site steward of the Contamination Control Strategy (CCS), to ensure appropriate cleanroom qualification, media fill (process simulation), environmental monitoring, and glove/sleeve integrity programs.
- Supports assessments related to qualification and validation of equipment, utilities, (e.g. HVAC, WFI), and fill / finish equipment (e.g. isolators).
- Ensure that suitable aseptic comportment/training/oversight programs are in place and effective. The programs should cover aseptic operators and the first line managers/quality staff charged with overseeing aseptic manufacturing and must be appropriate to the related tasks each person conducts.
- Participate as needed in investigation and resolution of aseptic failures, sterility test failures, EM excursions, adverse trends and related aseptic non-conformances.
- Review & approve any major/critical deviation and any change proposals with aseptic processing impact.
- Review and approve GMP documents related to aseptic processing, (SOPs, protocols, reports, batch records).
- Lead continuous improvement projects related to aseptic behavior, risk mitigation, and cleanroom operations.
Keys to Success
Education: Bachelor's degree in a Microbiology or similar/related technical field required.
Experience: Substantial experience, minimum 7-10 years' working in or directly supporting manufacturing within a sterile pharmaceutical manufacturing or aseptic manufacturing site. Strong working knowledge of the principles and guidelines for GMP as set out in the Eudralex Volume 4, U.S. 21CFR part 210/211 and able to operate as a subject matter expert on regulations pertaining to aseptic manufacturing such as EU Annex 1 and the FDA aseptic processing guide.
Knowledge, Skills, Abilities
- Deep understanding of GMP regulations and global quality standards
- Excellent communication and presentation skills
- Strong organizational and prioritization capabilities
- Skilled in technical writing and analytical problem-solving
- Collaborative leadership style with a continuous improvement mindset
Physical Requirements
- Ability to gown for cleanroom environments
- Capacity to read and review documentation for extended periods
- Must be able to talk, hear, sit, and stand for long durations
- Occasionally required to lift, walk, reach, stoop, kneel, or crouch
Requirements
- Bachelor's degree in Microbiology or similar/related technical field required
- Minimum 7-10 years' working in or directly supporting manufacturing within a sterile pharmaceutical manufacturing or aseptic manufacturing site
- Strong working knowledge of GMP principles and guidelines (Eudralex Volume 4, U.S. 21CFR part 210/211)
- Subject matter expert on regulations pertaining to aseptic manufacturing such as EU Annex 1 and the FDA aseptic processing guide
- Deep understanding of GMP regulations and global quality standards
- Excellent communication and presentation skills
- Strong organizational and prioritization capabilities
- Skilled in technical writing and analytical problem-solving
- Collaborative leadership style with a continuous improvement mindset
Benefits
- Medical plan
- Dental plan
- Vision plan
- Health incentive programs
- Employee assistance program
- Family support programs
- Commuter benefits
- Tuition reimbursement
- Paid time off
- Paid holidays
- Paid parental leave
- Accident insurance
- Life insurance
- Short-term disability
- Long-term disability
- 401(k) retirement savings plan
- Employees' stock purchase plan
- Annual incentive plan bonus
Company overview
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. The company's mission is to enable customers to make the world healthier, cleaner, and safer. With over 100,000 employees globally, Thermo Fisher provides an unrivaled combination of innovative technologies, purchasing convenience, and pharmaceutical services through its industry-leading brands including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD. The company serves customers across healthcare, life sciences, applied markets, and pharmaceutical sectors, offering solutions that accelerate research, solve complex analytical challenges, improve patient diagnostics, and increase laboratory productivity. Headquartered in Waltham, Massachusetts, Thermo Fisher operates globally, delivering critical scientific products, services, and workflow solutions that support researchers, organizations, and companies in addressing some of the world's most pressing issues.