Senior Validation Engineer

Aequor; Bend (OR); On-site; USD 90,000 - 120,000; Full time

Job summary

Aequor in Bend, Oregon seeks a CQV Validation Specialist to support qualification and validation activities within the CQV organization. The contractor will provide hands-on validation for analytical laboratory instruments, computerized systems, and GMP equipment in a regulated cGMP environment.

The role focuses on CQV and CSV tasks, with 100% onsite work in Bend and collaboration across QC, Instrumentation, Engineering, Automation, QA, and system owners to plan and execute validation activities.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Chemistry, Biology, or related field preferred.
• 3–5+ years of CQV/CSV experience in pharma/biotech or regulated industries.
• Experience with analytical lab instruments and equipment qualification.

Responsibilities

• Develop, execute, review, and maintain validation lifecycle documentation (URS, DS, RTM).
• Lead IQ/OQ/PQ execution and verification activities for instruments and equipment.
• Support CQV/CSV activities, calibration readiness, and data integrity tasks.
• Utilize Kneat validation platform for documents, routing, approvals, and closures.
• Collaborate with QC, Instrumentation, Engineering, QA to plan validation work.

Skills

CQV experience

CSV experience

GMP documentation

Analytical lab instruments

Regulated environment

Education

Bachelor's degree in Engineering or Life Sciences

Tools

Kneat

GxP documentation tools

Job description

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

Job Summary

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.

Key Responsibilities

• 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.

Required Qualifications

Education

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

Experience

• 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.

Technical Skills

• 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.

Preferred Analytical Laboratory Experience

Experience supporting qualification or validation of laboratory instruments such as HPLC, GC, FTIR, UV‑Vis, Karl Fischer, balances, pH/conductivity meters, dissolution systems, chromatography systems, or other GMP laboratory equipment is highly desirable.

• Excellent technical writing and documentation skills.
• Strong organizational and time‑management skills.
• Ability to prioritize competing CQV and CSV activities.
• Strong attention to detail and data integrity awareness.
• Proactive problem‑solving and discrepancy resolution skills.
• Ability to work independently with minimal supervision.
• Strong communication and cross‑functional collaboration skills.
• Ability to operate effectively in a regulated cGMP environment.
• Strong commitment to quality, compliance, and inspection readiness.

Physical & Environmental Requirements

• Work onsite within a clean, secure, regulated GMP environment.
• Follow all applicable site safety and GMP requirements.
• Wear required PPE, including lab coats, safety glasses, gloves, and other protective equipment as required.
• Occasional lifting of up to 50 pounds.
• Travel between campus buildings as required for qualification and field execution activities.
• Flexibility to support project and field execution activities as needed.