Senior Validation Engineer

Interview Process: Initial Teams interview followed by a panel interview via Teams or onsite. Onsite interview may be required.

We are seeking a CQV Validation Specialist to support a high-priority backlog of qualification and validation activities within the CQV organization. The contractor will provide hands‑on validation support for analytical laboratory instruments, computerized systems, and GMP equipment in a regulated cGMP environment.

This role will work closely with both the CQV and Instrumentation teams
, balancing priorities across equipment qualification, computerized systems validation (CSV), documentation, and field execution activities. Candidates with a combination of CSV and CQV experience
, particularly within analytical laboratory environments, are highly preferred.

Due to the hands‑on nature of the work,
100% onsite presence in Bend, Oregon is required
.

• Develop, execute, review, and maintain validation lifecycle documentation, including:
• User Requirements Specifications (URS)
• Design Specifications
• Traceability Matrices (RTM)
• Test Scripts
• Validation Protocols
• Discrepancies and Deviations
• Validation Summary Reports
• Periodic Review documentation
• Support qualification and validation activities for analytical laboratory instruments, computerized systems, and GMP equipment
  .
• Execute and support IQ, OQ, and PQ activities.
• Support calibration readiness, data integrity verification, and compliance with 21 CFR Part 11 and EU Annex 11
  .
• Partner with QC, Instrumentation, Engineering, Automation, QA, and system owners to plan and execute validation activities.
• Prepare and support change controls, impact assessments, deviations, CAPAs, and validation protocols
  .
• Utilize the Kneat validation platform for document creation, workflow routing, approvals, and record closure.
• Assist with Kneat template development and validation process improvements.
• Maintain accurate, complete, and inspection‑ready documentation in accordance with SOPs, GxP requirements, and site procedures.
• Monitor field execution activities, identify gaps, support discrepancy resolution, and escalation issues when appropriate.
• Provide CSV support to the Instrumentation team while supporting CQV priorities related to qualification execution, documentation updates, and readiness activities.
• Work onsite across Bend campus buildings as needed to support laboratory instrument and equipment qualification.
• Manage multiple validation activities and competing priorities in a fast‑paced regulated environment.
• Perform other duties as assigned.

• Bachelor's degree in Engineering, Life Sciences, Chemistry, Biology, or a related scientific discipline preferred.

• 3–5+ years of CQV and/or CSV experience within pharmaceutical, biotechnology, medical device, or another regulated industry.
• Experience supporting analytical laboratory instruments and equipment qualification
  .
• Strong experience working in a cGMP/GxP‑regulated environment
  .
• Experience with computerized systems validation and equipment qualification
  .
• Experience managing multiple validation projects and competing priorities.
• Experience supporting validation backlog remediation or high‑volume qualification/validation activities is highly desirable.
• Analytical laboratory experience is strongly preferred.
• Candidates with both CSV and CQV experience are highly preferred.

• Hands‑on experience with Kneat validation/documentation software
  .
• Strong knowledge of GMP documentation and validation lifecycle practices.
• Experience with IQ/OQ/PQ and equipment qualification.
• Knowledge of:
• GxP regulations
• FDA 21 CFR Part 11
• 21 CFR Parts 210 and 211
• EU Annex 11
• EU Annex 15
• USP standards
• ASTM standards
• Understanding of computerized systems, laboratory instruments, pharmaceutical manufacturing equipment, specifications, procedures, and engineering documentation.
• Understanding of the differences between equipment qualification, instrument qualification, and computerized systems validation
  .
• Familiarity with analytical laboratory equipment and systems is strongly preferred.

Experience supporting qualification or validation of…