Work ScheduleStandard (Mon-Fri)
Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job DescriptionTitle: Sterility Assurance ManagerDivision/Site Specific InformationThermo Fisher Scientific - Viral Vector Services (VVS) is a multifaceted gene therapy contract development and manufacturing organization (CDMO) that is seeking sharp individuals to bring the highest quality processes, products and testing to our clients. Our employees are committed to making a difference in our organization for our client partners and the patients we serve.
Pharma Services | Viral Vectors | 5 Commerce Drive, Plainville, MA | 100% OnsiteDiscover Impactful Work: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).
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
BenefitsWe offer competitive remuneration, annual incentive plan bonus scheme, healthcare, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.
Compensation and BenefitsThe salary range estimated for this position based in Massachusetts is $103,100.00-$154,700.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
- A choice of national medical and dental plans, and a national vision plan, 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 and life insurance, and short- and long-term disability in accordance with company policy
- Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
- Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards
