CQV / CSV Engineer – IQ/OQ/PQ | Analytical Laboratory
Job in
Bend, Deschutes County, Oregon, 97707, USA
Listed on 2026-08-23
Listing for:
JMD Technologies Inc.
Full Time
position Listed on 2026-08-23
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist, QA Specialist - Analyst/Manager
Job Description & How to Apply Below
Title: CQV / CSV Engineer – IQ/OQ/PQ | Analytical Laboratory
Employment Type: Contract – 9 Months
Status: Accepting Candidates
About the roleSeeking a CQV / CSV Engineer to support qualification and validation activities for analytical laboratory instruments, computerized systems, and GMP equipment
. This role will help address a significant validation backlog while partnering with Instrumentation, Quality Control, Engineering, Automation, and Quality Assurance teams.
- Develop, execute, review, and maintain validation lifecycle documentation
, including URS, risk assessments, protocols, test scripts, traceability matrices, and summary reports. - Execute and support IQ/OQ/PQ activities for analytical laboratory instruments, computerized systems, and GMP equipment.
- Support CSV activities, including data integrity verification and compliance with 21 CFR Part 11 and EU Annex 11.
- Manage deviations, CAPAs, change controls, and impact assessments related to validation activities.
- Utilize the Kneat validation platform for document creation, workflow routing, approvals, and record closure.
- Monitor field execution, identify gaps, drive discrepancy resolution, and maintain inspection‑ready documentation.
- 3–5+ years of CQV and/or CSV experience within pharmaceutical, biotechnology, or other regulated industries.
- Hands‑on experience with analytical laboratory instruments and equipment qualification
. - Strong experience in cGMP/GxP-regulated environments and GMP documentation practices.
- Knowledge of 21 CFR Part 11, 21 CFR Parts 210/211, EU Annex 11, and Annex 15
. - Proven experience with Kneat validation/documentation software.
- Bachelor's degree in Engineering, Life Sciences, Chemistry, Biology, or related scientific discipline preferred.
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