Validation Engineer

Contractor – CSV/CQV Specialist *Location:* Bend, OR — 100% Onsite *Duration:* 6–9 Month Contract *Schedule:* Full-time, onsite *Interview:* Initial Teams interview + Panel interview (Teams or onsite) Role Summary We 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. This 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. *100% onsite presence in Bend, Oregon is required.* Key Responsibilities * Develop, execute, review, and maintain validation lifecycle documentation, including: * Risk Assessments * URS / Design Specifications * Traceability Matrices * Test Scripts * IQ/OQ/PQ Protocols * Discrepancies / Deviations * Validation Summary Reports * Periodic Reviews * System Retirement Documentation * Support qualification and validation of *analytical laboratory instruments, computerized systems, and GMP equipment*. * Execute and support *IQ, OQ, and PQ* activities. * Support calibration readiness and *data integrity verification*. * Support compliance with *21 CFR Part 11 and Annex 11*. * Partner with QC, Instrumentation, Engineering, Automation, QA, and system owners. * Support *Change Controls, Impact Assessments, Deviations, CAPAs, and validation protocols*. * Utilize *Kneat* for document creation, workflow routing, approvals, and record closure. * Assist with *Kneat template development* and continuous improvement. * Maintain inspection-ready validation documentation. * Monitor field execution, identify qualification gaps, resolve discrepancies, and escalate issues. * Balance priorities between *Instrumentation/CSV and CQV activities*. * Travel between Bend campus buildings as needed for instrument and equipment qualification. Required Qualifications * Bachelor's degree in Engineering, Life Sciences, Chemistry, Biology, or related scientific discipline preferred. * *3–5+ years of CQV and/or CSV experience* in pharmaceutical, biotechnology, or another regulated environment. * Hands-on experience with *analytical laboratory instruments/equipment qualification*. * Experience working in a *cGMP environment*. * Experience with *Computerized Systems Validation (CSV)* and *Equipment Qualification (EQ)*. * Experience managing multiple validation projects and competing priorities. * Strong technical writing and validation documentation experience. * *Kneat experience strongly preferred/required.* * Knowledge of GxP, *21 CFR Part 11, 21 CFR 210/211, EU Annex 11, and Annex 15*. * Understanding of laboratory instruments, computerized systems, pharmaceutical equipment, specifications, procedures, and engineering drawings. * Ability to distinguish *equipment qualification vs. computerized system/instrument validation*. Pay: $80.00 - $100.00 per hour Application Question(s): * Are you local to Oregon? * How many years of hands-on CQV and/or CSV experience do you have in a pharmaceutical, biotech, or other GMP-regulated environment? * Have you personally supported qualification or validation of analytical laboratory instruments? If yes, which instruments have you personally worked on? * Have you used Kneat for validation documentation? What exactly did you do in Kneat? * Walk me through one piece of equipment or laboratory instrument that you personally qualified. What did you do during IQ, OQ, and PQ? Work Location: In person