Validation Engineer

Are you an experienced PCS 7 Validation Engineer with a passion for automation and compliance? This is an exciting opportunity to play a critical role in validating Siemens PCS 7 control systems within a regulated GxP this role, you will be responsible for creating and maintaining key validation documentation while ensuring that automated processes are compliant with industry standards (FDA 21 CFR Part 11, EU Annex 11, GAMP 5). While the primary focus is documentation, you may also provide hands-on support during execution of validation activities on-site.What you’ll be doing:Developing and maintaining CSV templates and test protocols for Siemens PCS 7 systemsCollaborating with Automation, Manufacturing, Quality, and Engineering teams to define testing requirementsEnsuring all documentation meets GAMP 5, SOPs, and regulatory expectationsSupporting execution of validation protocols, including setup, witnessing, documentation, and troubleshootingRecording and supporting investigations into deviations and non-conformancesPreparing summary reports to capture validation outcomesWhat we’re looking for:3+ years of validation experience in a GxP-regulated industry (Pharma, Bio-Pharma, Medical Device, etc.)Strong, hands-on knowledge of Siemens PCS 7 architecture and components (OS, BATCH, Historian, etc.)Solid understanding of FDA 21 CFR Part 11, EU Annex 11, and GAMP 5Exceptional technical writing and communication skillsAbility to work independently and manage multiple priorities in a fast-paced environmentThis is a fantastic opportunity for a motivated validation professional to contribute to critical life science projects while developing their expertise with Siemens PCS 7 in a regulated setting.Seniority levelSeniority levelMid-Senior levelEmployment typeEmployment typeContractJob functionIndustriesPharmaceutical ManufacturingReferrals increase your chances of interviewing at Skills Alliance by 2xSign in to set job alerts for “Validation Engineer” roles.Seattle, WA $80,000.00-$110,000.00 6 days agoMount Vernon, WA $78,000.00-$85,000.00 13 hours agoProcess Engineer - Analytical and Process TestingRedmond, WA $90,000.00-$115,000.00 2 weeks agoGreater Seattle Area $80,000.00-$85,000.00 2 days agoRedmond, WA $110,000.00-$145,000.00 2 weeks agoSpecialist QA Validation/ Sr. Specialist, QA ValidationSpokane, WA $77,968.80-$113,900.00 2 weeks agoBothell, WA $80,000.00-$106,000.00 1 week agoBothell, WA $97,440.00-$155,904.00 15 hours agoSpecialist of QA Validation/ Senior Specialist of QA ValidationSpokane, WA $77,968.80-$113,900.00 1 week agoMedina, WA $66,974.00-$90,414.00 1 day agoBellevue, WA $80,000.00-$110,000.00 6 days agoEverett, WA $25,000.00-$110,000.00 4 hours agoRedmond, WA $111,000.00-$164,000.00 2 weeks agoIn-service/Fleet/Field Quality Engineer, Quality Engineering TeamSeattle, WA $128,600.00-$213,600.00 1 week agoQuality Engineer II -Semiconductor ManufacturingBellevue, WA $65,000.00-$75,000.00 17 hours agoRedmond, WA $139,000.00-$200,000.00 2 weeks agoBellevue, WA $65,000.00-$75,000.00 17 hours agoIn-service/Fleet/Field Quality Engineer, Quality Engineering TeamSeattle, WA $105,600.00-$185,000.00 2 weeks agoRedmond, WA $139,000.00-$200,000.00 1 week agoBusiness Quality Tester -Pharma (Hybrid – Seattle, WA)Bothell, WA $85,000.00-$100,000.00 1 week agoSr. Supplier Quality Engineer, Prime AirSeattle, WA $128,600.00-$213,600.00 1 week agoWe’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr

Created: 2025-09-17