Validation Engineer - Pharma - 6 Month Contract

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Located in Bend, OR

Salary: Competitive Pay Rate!

We are seeking a Validation Engineer - CSV/CQV Specialist for 6+ month onsite contract role in Bend, Oregon. 

The CSV/CQV Specialist will support a high-priority backlog of qualification and validation activities within the CQV department. This role will provide validation support for analytical laboratory instruments, computerized systems, and GMP equipment while partnering closely with both the Instrumentation and CQV teams.

This individual must be comfortable managing multiple priorities simultaneously, producing high-quality documentation, and working hands-on with laboratory instruments and equipment in a regulated cGMP environment. Because the position supports physical equipment and instrument qualification activities, onsite presence in Bend, Oregon is required.

What You Get to Do! 
•    Develop, execute, review, and maintain validation lifecycle documentation, including:
•    Risk Assessments
•    User Requirement Specifications (URS)
•    Design Specifications
•    Traceability Matrices
•    Test Scripts
•    Validation Protocols
•    Discrepancies and Deviations
•    Summary Reports
•    Periodic Review Documentation
•    System Retirement Documentation
•    Support qualification and validation activities for new and existing analytical laboratory instruments, computerized systems, and GMP equipment.
•    Execute and support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities.
•    Ensure calibration readiness, data integrity verification, and compliance with 21 CFR Part 11 and Annex 11 requirements.
•    Partner with Quality Control, Instrumentation, Engineering, Automation, Quality Assurance, and system owners to plan and execute validation activities.
•    Prepare and support change controls, impact assessments, deviations, CAPAs, and validation protocols related to GMP equipment, analytical instruments, and computerized systems.
•    Utilize and support the Kneat validation platform, including document creation, workflow routing, approvals, and record closure.
•    Assist with Kneat template development and continuous improvement initiatives.
•    Maintain inspection-ready documentation in accordance with SOPs, GxP requirements, and site procedures.
•    Monitor field execution activities, identify gaps early, drive discrepancy resolution, and escalate issues as appropriate.
•    Split support between the Instrumentation team for CSV activities and the CQV group for qualification execution, documentation updates, and readiness activities.

What You Will Bring…
•    Bachelor's Degree in Engineering, Life Sciences, Chemistry, Biology, or a related scientific discipline preferred.
•    Minimum of 3 years of CQV and/or CSV experience within pharmaceutical, biotechnology, or other regulated industries.
•    Experience supporting analytical laboratory instruments and equipment qualification.
•    Experience working in cGMP-regulated environments.
•    Experience with computerized systems validation and equipment qualification.
•    Experience managing multiple validation projects and competing priorities.
•    Previous backlog remediation or high-volume validation support experience is highly desirable.
•    Proven experience using Kneat validation/documentation software.
•    Strong understanding of GMP documentation requirements and validation practices.
•    GxP regulations
•    21 CFR Part 11
•    21 CFR Parts 210 and 211
•    EU Annex 11
•    Annex 15
•    USP and ASTM standards
•    Understanding of computerized systems, laboratory instruments, pharmaceutical manufacturing equipment, specifications, procedures, and engineering drawings.
•    Strong understanding of equipment qualification versus instrument validation requirements.

To Apply: 
For confidential consideration, please submit resume to karen.turner@expresspros.com  

Apply Now