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Join to apply for theMS&T Director, Validation Lead Sterilesrole atThermo Fisher Scientific 3 days ago Be among the first 25 applicants Join to apply for theMS&T Director, Validation Lead Sterilesrole atThermo Fisher Scientific Work ScheduleStandard Office Hours (40/wk)Environmental ConditionsOfficePosition: MS&T Director, Validation Lead SterilesReports To: DPD Division MSAT HeadLocation: Remote US / EUPreferred Locations:North Carolina (US): Greenville France, Bourgoin Italy: Monza & Ferentino UK: SwindonThese locations are key sites for our operations.FTE Responsibility: No direct resources, leads influentially through the matrix across sterile network globallyPosition summaryJoin our dynamic DPD MSAT distributed team as a Validation Lead Steriles! This outstanding opportunity offers the chance to bring to bear your deep specialist knowledge and expertise in validation for both cleaning and process. You’ll work closely with site General Managers and their Site Leadership Teams to develop validation strategies for new and existing processes. Your role will be pivotal in setting validation standards aligned with up-to-date Regulatory mentorship, reducing compliance risks, and building standard methodologies across our sterile drug product sites.Key responsibilitiesManufacturing Support:Set global procedures & templates for cleaning and process validation documentation and validation master plan. Develop strategy for continued process verification (CPV) and annual monitoring batches. Support sites during Regulatory inspections to ensure flawless inspections. Provide expert technical support in aseptic manufacturing, validation, new technologies, and sterilization. Continuously monitor GMP, EU, and FDA regulatory changes. Partner with Engineering and IT to define the process validation/equipment/systems qualification interface. Identify and drive opportunities for improvement in process effectiveness, product quality, and operating efficiency. Own the Training Curriculum for cleaning and process validation and technologies.Stewardship for Aseptic Network & New Product Launch:Act as the Network SME for collaborating with the Local and global MSAT network. Assure necessary benchmarking internally and externally to stimulate knowledge expansion. Author and implement GOPs for assigned technology.Qualifications And RequirementsMSc or equivalent experience in Pharmacy, Pharmaceutical Technology, Chemistry, or a related scientific field. 10+ years professional experience in GMP manufacturing; previous experience in relevant MST roles is mandatory. Proven process understanding (Pharma, GMP, Regulatory aspects). Up to 40% international travel, as needed. Confident communicator both verbally and in writing. Able to influence others and build cross-functional teams while setting clear business objectives. Demonstrated leadership and technical experience.Seniority levelSeniority level Not Applicable Employment typeEmployment type Full-time Job functionJob function Production, Supply Chain, and Manufacturing Industries Hospitals and Health Care, Non-profit Organizations, and Government Administration Referrals increase your chances of interviewing at Thermo Fisher Scientific by 2x Sign in to set job alerts for “Lead Director” roles.Senior Director, International (UK Remote or In the Office)United Kingdom $100,000.00-$130,000.00 1 week ago London, England, United Kingdom 3 months ago Operations Director - Professional Services SMENorthampton, England, United Kingdom £90,000.00-£120,000.00 3 weeks ago Global Head of Ad Operations & Account Management (Remote, Europe)London, England, United Kingdom 5 days ago Regional Managing Director / Self Employed PartnerDirector - Marketing Business Partnering & DeliveryLondon, England, United Kingdom 1 week ago Director of Government Business Development, EU/MELondon, England, United Kingdom 1 month ago Business Development Director - Comparators - RemoteAssociate Director/ Director Business DevelopmentBusiness Development Director Europe- Eurofins Central LaboratoryLondon, England, United Kingdom 3 weeks ago London, England, United Kingdom 4 months ago Operations Director - Health Sector (Elderly Care Services)We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.#J-18808-Ljbffr