Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence 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 Description
Title: 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. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Division/Site Specific Information
Thermo 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% Onsite
Discover 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…