{"schemaVersion":"jobsearcher.job.v1","id":"9ec94dda0f6c80e1e7f5bf84","url":"https://jobsearcher.com/jobs/9ec94dda0f6c80e1e7f5bf84","canonicalUrl":"https://jobsearcher.com/jobs/9ec94dda0f6c80e1e7f5bf84","title":"Validation Engineer","description":"Contractor – CSV/CQV Specialist\n\n*Location:* Bend, OR — 100% Onsite\n*Duration:* 6–9 Month Contract\n*Schedule:* Full-time, onsite\n*Interview:* Initial Teams interview + Panel interview (Teams or onsite)\n\nRole Summary\n\nWe are seeking a *CSV/CQV Specialist* to support a significant backlog of qualification and validation activities within the CQV organization. The contractor will support both *analytical laboratory instrument qualification* and *computerized systems validation (CSV)* activities.\n\nThis position will work closely with the *CQV and Instrumentation teams*, splitting time between equipment qualification, validation documentation, and CSV activities. The ideal candidate will have hands-on experience in a *cGMP pharmaceutical/biotechnology environment*, strong documentation skills, and the ability to manage multiple validation priorities.\n\n*100% onsite presence in Bend, Oregon is required.*\n\nKey Responsibilities\n\n* Develop, execute, review, and maintain validation lifecycle documentation, including:\n* Risk Assessments\n* URS / Design Specifications\n* Traceability Matrices\n* Test Scripts\n* IQ/OQ/PQ Protocols\n* Discrepancies / Deviations\n* Validation Summary Reports\n* Periodic Reviews\n* System Retirement Documentation\n* Support qualification and validation of *analytical laboratory instruments, computerized systems, and GMP equipment*.\n* Execute and support *IQ, OQ, and PQ* activities.\n* Support calibration readiness and *data integrity verification*.\n* Support compliance with *21 CFR Part 11 and Annex 11*.\n* Partner with QC, Instrumentation, Engineering, Automation, QA, and system owners.\n* Support *Change Controls, Impact Assessments, Deviations, CAPAs, and validation protocols*.\n* Utilize *Kneat* for document creation, workflow routing, approvals, and record closure.\n* Assist with *Kneat template development* and continuous improvement.\n* Maintain inspection-ready validation documentation.\n* Monitor field execution, identify qualification gaps, resolve discrepancies, and escalate issues.\n* Balance priorities between *Instrumentation/CSV and CQV activities*.\n* Travel between Bend campus buildings as needed for instrument and equipment qualification.\n\nRequired Qualifications\n\n* Bachelor's degree in Engineering, Life Sciences, Chemistry, Biology, or related scientific discipline preferred.\n* *3–5+ years of CQV and/or CSV experience* in pharmaceutical, biotechnology, or another regulated environment.\n* Hands-on experience with *analytical laboratory instruments/equipment qualification*.\n* Experience working in a *cGMP environment*.\n* Experience with *Computerized Systems Validation (CSV)* and *Equipment Qualification (EQ)*.\n* Experience managing multiple validation projects and competing priorities.\n* Strong technical writing and validation documentation experience.\n* *Kneat experience strongly preferred/required.*\n* Knowledge of GxP, *21 CFR Part 11, 21 CFR 210/211, EU Annex 11, and Annex 15*.\n* Understanding of laboratory instruments, computerized systems, pharmaceutical equipment, specifications, procedures, and engineering drawings.\n* Ability to distinguish *equipment qualification vs. computerized system/instrument validation*.\n\nPay: $80.00 - $100.00 per hour\n\nApplication Question(s):\n* Are you local to Oregon?\n* How many years of hands-on CQV and/or CSV experience do you have in a pharmaceutical, biotech, or other GMP-regulated environment?\n* Have you personally supported qualification or validation of analytical laboratory instruments? If yes, which instruments have you personally worked on?\n* Have you used Kneat for validation documentation? What exactly did you do in Kneat?\n* Walk me through one piece of equipment or laboratory instrument that you personally qualified. What did you do during IQ, OQ, and PQ?\n\nWork Location: In person","company":"Proaxis Solutions","rawCompany":"proaxis solutions","city":"North Bend","state":"WA","isRemote":false,"isActive":false,"createdAt":"2026-08-22T13:42:22.284Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"}],"industries":[{"code":"541690","title":"Other Scientific and Technical Consulting Services","slug":"other-scientific-and-technical-consulting-services"},{"code":"541330","title":"Engineering Services","slug":"engineering-services"},{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Validation Engineer","description":"Contractor – CSV/CQV Specialist\n\n*Location:* Bend, OR — 100% Onsite\n*Duration:* 6–9 Month Contract\n*Schedule:* Full-time, onsite\n*Interview:* Initial Teams interview + Panel interview (Teams or onsite)\n\nRole Summary\n\nWe are seeking a *CSV/CQV Specialist* to support a significant backlog of qualification and validation activities within the CQV organization. The contractor will support both *analytical laboratory instrument qualification* and *computerized systems validation (CSV)* activities.\n\nThis position will work closely with the *CQV and Instrumentation teams*, splitting time between equipment qualification, validation documentation, and CSV activities. The ideal candidate will have hands-on experience in a *cGMP pharmaceutical/biotechnology environment*, strong documentation skills, and the ability to manage multiple validation priorities.\n\n*100% onsite presence in Bend, Oregon is required.*\n\nKey Responsibilities\n\n* Develop, execute, review, and maintain validation lifecycle documentation, including:\n* Risk Assessments\n* URS / Design Specifications\n* Traceability Matrices\n* Test Scripts\n* IQ/OQ/PQ Protocols\n* Discrepancies / Deviations\n* Validation Summary Reports\n* Periodic Reviews\n* System Retirement Documentation\n* Support qualification and validation of *analytical laboratory instruments, computerized systems, and GMP equipment*.\n* Execute and support *IQ, OQ, and PQ* activities.\n* Support calibration readiness and *data integrity verification*.\n* Support compliance with *21 CFR Part 11 and Annex 11*.\n* Partner with QC, Instrumentation, Engineering, Automation, QA, and system owners.\n* Support *Change Controls, Impact Assessments, Deviations, CAPAs, and validation protocols*.\n* Utilize *Kneat* for document creation, workflow routing, approvals, and record closure.\n* Assist with *Kneat template development* and continuous improvement.\n* Maintain inspection-ready validation documentation.\n* Monitor field execution, identify qualification gaps, resolve discrepancies, and escalate issues.\n* Balance priorities between *Instrumentation/CSV and CQV activities*.\n* Travel between Bend campus buildings as needed for instrument and equipment qualification.\n\nRequired Qualifications\n\n* Bachelor's degree in Engineering, Life Sciences, Chemistry, Biology, or related scientific discipline preferred.\n* *3–5+ years of CQV and/or CSV experience* in pharmaceutical, biotechnology, or another regulated environment.\n* Hands-on experience with *analytical laboratory instruments/equipment qualification*.\n* Experience working in a *cGMP environment*.\n* Experience with *Computerized Systems Validation (CSV)* and *Equipment Qualification (EQ)*.\n* Experience managing multiple validation projects and competing priorities.\n* Strong technical writing and validation documentation experience.\n* *Kneat experience strongly preferred/required.*\n* Knowledge of GxP, *21 CFR Part 11, 21 CFR 210/211, EU Annex 11, and Annex 15*.\n* Understanding of laboratory instruments, computerized systems, pharmaceutical equipment, specifications, procedures, and engineering drawings.\n* Ability to distinguish *equipment qualification vs. computerized system/instrument validation*.\n\nPay: $80.00 - $100.00 per hour\n\nApplication Question(s):\n* Are you local to Oregon?\n* How many years of hands-on CQV and/or CSV experience do you have in a pharmaceutical, biotech, or other GMP-regulated environment?\n* Have you personally supported qualification or validation of analytical laboratory instruments? If yes, which instruments have you personally worked on?\n* Have you used Kneat for validation documentation? What exactly did you do in Kneat?\n* Walk me through one piece of equipment or laboratory instrument that you personally qualified. What did you do during IQ, OQ, and PQ?\n\nWork Location: In person","datePosted":"2026-08-22T13:42:22.284Z","dateModified":"2026-08-22T13:42:22.284Z","hiringOrganization":{"@type":"Organization","name":"Proaxis Solutions","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"North Bend","addressRegion":"WA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"9ec94dda0f6c80e1e7f5bf84"},"url":"https://jobsearcher.com/jobs/9ec94dda0f6c80e1e7f5bf84"}}