Staff Validation Engineer, Process and Cleaning

Staff Engineer, Process and Cleaning ValidationWork ScheduleFirst Shift (Days)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, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)Job DescriptionHow will you make an impact?The Staff Engineer, Process and Cleaning Validation supports Thermo Fisher's mission by ensuring manufacturing processes and cleaning procedures are validated, compliant, and capable of consistently delivering high-quality products in a sterile/aseptic environment.What will you do?Lead process validation (PPQ) and cleaning validation activitiesDevelop validation strategies for new and existing products and processesAuthor and execute validation protocols and reportsPerform data analysis to support validation conclusionsSupport change controls, deviations, and CAPAsCollaborate with Manufacturing, Quality, and MS&T teamsEnsure alignment with cGMP and regulatory expectationsSupport internal and external audits and inspectionsHow will you get here?Education:Bachelor's degree in Engineering, Chemistry, Life Sciences, or related fieldExperience:8+ years of experience in process and/or cleaning validationExperience in sterile/aseptic manufacturing environments (required)Strong knowledge of cleaning validation, including residue limits and risk-based approachesExperience with lifecycle validation and PPQKnowledge, Skills, Abilities:Strong understanding of cGMP and regulatory requirementsData analysis and problem-solving skillsTechnical writing and documentation expertiseAbility to manage multiple projects and prioritiesStrong cross-functional collaboration skills