CQV/CSV Engineer - IQ/OQ/PQ for Analytical Lab Systems

JMD Technologies Inc.; Bend (OR); On-site; USD 85,000 - 110,000; Full time

Job summary

JMD Technologies Inc. seeks a CQV/CSV Engineer to support qualification and validation activities for analytical laboratory instruments, computerized systems, and GMP equipment.

The role addresses a validation backlog and collaborates with Instrumentation, Quality Control, Engineering, Automation, and Quality Assurance teams. Responsibilities include developing validation lifecycle documentation, executing IQ/OQ/PQ, and ensuring CSV compliance with 21 CFR Part 11 and EU Annex 11.

Qualifications

• 3–5+ years CQV/CSV experience in pharmaceutical or regulated industries.
• Hands-on experience with analytical laboratory instruments and equipment qualification.
• Strong experience in cGMP/GxP 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 discipline preferred.

Responsibilities

• Develop, execute, review, and maintain validation lifecycle documentation (URS, risk assessments, protocols, test scripts, traceability matrices, reports).
• Execute and support IQ/OQ/PQ activities for analytical lab 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, routing, approvals, and record closure.
• Monitor field execution, identify gaps, drive discrepancy resolution, and maintain inspection-ready documentation.

Job description

JMD Technologies Inc. seeks a CQV/CSV Engineer to support qualification and validation activities for analytical laboratory instruments, computerized systems, and GMP equipment.

The role addresses a validation backlog and collaborates with Instrumentation, Quality Control, Engineering, Automation, and Quality Assurance teams. Responsibilities include developing validation lifecycle documentation, executing IQ/OQ/PQ, and ensuring CSV compliance with 21 CFR Part 11 and EU Annex 11.