Staff Validation Engineer, Media Fills

Staff Engineer, Media FillWork 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, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)Job DescriptionHow will you make an impact?As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. The Staff Engineer, Media Fill plays a critical role in supporting sterile/aseptic manufacturing operations by leading media fill (aseptic process simulation) programs.

This role ensures processes remain in a validated state and compliant with global regulatory expectations.What will you do?Lead the design and execution of media fill (APS) studies for aseptic manufacturing processesAuthor and review validation protocols, reports, and risk assessmentsSupport investigations, deviations, and CAPAs related to media fills and aseptic processesPartner cross-functionally with Manufacturing, Quality, and Regulatory teamsEnsure compliance with cGMP, FDA, EMA, and global regulatory requirementsDrive continuous improvement initiatives in validation and contamination control strategiesHow will you get here?Education:Bachelor's degree in Engineering, Life Sciences, or related fieldExperience:8+ years of experience in pharmaceutical/biotech validationStrong experience with aseptic processing and media fill execution (required)Experience in sterile manufacturing environments (required)Knowledge, Skills, Abilities:Deep understanding of aseptic processing and contamination controlStrong knowledge of cGMP and regulatory expectationsTechnical writing expertise (validation protocols and reports)Ability to lead complex validation projects independentlyStrong collaboration and communication skills