Sterility Assurance Manager

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer.

About the role

Manager Sterility Assurance is responsible for establishing, maintaining, and continuously improving the site’s strategy at a sterile fill / finish manufacturing facility. This role drives compliance with regulatory requirements (FDA, EMA, PIC/S, Annex 1) and sterility assurance initiatives, microbiological oversight collaboration, and aseptic assurance across the manufacturing site. The position serves as the subject matter expert (SME) for aseptic practices, maintenance of aseptic observation program data metrics, and the overall contamination control strategy (CCS).

Responsibilities

• 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 Environmental Monitoring (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.
• Collaborate 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.
• Support 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, and oversight programs are in place and effective for aseptic operators and first-line managers/quality staff.
• Participate as needed in investigation and resolution of aseptic failures, sterility test failures, EM excursions, adverse trends, and related aseptic non-conformances.
• Review and approve any major/critical deviation and 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.

Requirements

• Bachelor’s degree in Microbiology or a similar/related technical field required.
• Minimum 7–10 years’ experience working in or directly supporting manufacturing within a sterile pharmaceutical or aseptic manufacturing site.
• Strong working knowledge of GMP principles and guidelines as set out in Eudralex Volume 4, U.S. 21 CFR parts 210/211, EU Annex 1, and the FDA aseptic processing guide.

Skills

• 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.

Environmental Conditions

• Adherence to all Good Manufacturing Practices (GMP) and safety standards.
• Cleanroom environment: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, or facial hair allowed.
• Laboratory and office setting.
• Personal Protective Equipment (PPE) required, including safety glasses, gowning, gloves, lab coat, and ear plugs.

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.

Schedule

Standard (Monday–Friday).

Pay

The salary range for this position based in Massachusetts is $103,100.00–$154,700.00. This position may also be eligible for a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.

Benefits

• Comprehensive medical, dental, and vision plans, including health incentive programs.
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement.
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave).
• Accident, life, short-term, and long-term disability insurance.
• Retirement and savings programs, including a competitive 401(k) U.S. retirement savings plan.
• Employees’ Stock Purchase Plan (ESPP) with the opportunity to purchase company stock at a discount.