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Engineer III, Validation - Process & Cleaning

Thermo Fisher Scientific

Engineer III, Validation - Process & Cleaning

full-timePosted: Aug 2, 2026Updated: Sep 1, 2026USA, North Carolina, Greenville

Job Description

Work ScheduleStandard (Mon-Fri)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, OfficeJob DescriptionDiscover Impactful Work:Join Thermo Fisher Scientific and be part of a team delivering life-changing therapies through world-class sterile pharmaceutical manufacturing.As a Validation Engineer III, you will lead validation activities supporting process and cleaning validation in sterile environments, playing a key role in ensuring compliance, quality, and successful product launches.This role offers high visibility and cross-functional exposure, working across Operations, Quality, and QC Labs—often acting as a technical lead during tech transfers and validation execution.A Day in the Life:~70% desk-based: protocol writing, data analysis, deviation investigations, reporting~30% on the floor: executing validation in sterile manufacturing environmentsLead validation activities including:Process validationCleaning validationEquipment qualification (IQ/OQ/PQ)Support tech transfers and new product introductionsCollaborate cross-functionally with Ops, QC, and Quality teamsParticipate in client interactions, audits, and regulatory readinessWhat to Expect:Ownership of complex validation projectsHigh exposure across site operations and leadership teamsOpportunity to act in a project management capacityInvolvement in audits, deviations, and continuous improvementKeys to Success:Education & Experience:Bachelor’s degree and 4+ years validation experienceExperience in pharmaceutical or biotech manufacturing requiredDirect experience in sterile/aseptic pharmaceutical manufacturing highly preferred:Aseptic fillingSterile processingCleanroom environmentsSkills & Expertise:Strong experience with:Process validationCleaning validationEquipment qualification (IQ/OQ/PQ)Proven ability to write and execute validation protocols and reportsExperience with validation documentation and regulatory standardsExposure to audits, audit responses, or regulatory inspectionsStrong problem-solving and deviation investigation skillsPreferred:Experience in both process and cleaning validationBackground in sterile filling or manufacturing operationsKnowledge of FDA, EMA, and cGMP regulationsWork Environment & Requirements:Onsite role in Greenville, NCMonday–Friday schedule with flexibility as neededCleanroom and production floor exposure requiredWhy Join Us:Work on cutting-edge sterile pharmaceutical programsGain broad cross-functional exposure across the siteBe part of high-impact tech transfers and product launchesClear path to senior and leadership roles

Locations

  • USA, North Carolina, Greenville

Skills Required

  • both processintermediate
  • sterile fillingintermediate
  • FDAintermediate

Required Qualifications

  • Onsite role in Greenville, NC (experience)
  • Monday–Friday schedule with flexibility as needed (experience)
  • Cleanroom and production floor exposure required (experience)

Preferred Qualifications

  • Experience in both process and cleaning validation (experience)
  • Background in sterile filling or manufacturing operations (experience)
  • Knowledge of FDA, EMA, and cGMP regulations (experience)

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