Validation Engineer - Bend, OR

Title: CSV/CQV Specialist

Position Summary:

• Client is seeking a contractor-level CSV/CQV Specialist to 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.
• The successful candidate will split time supporting Dawn Bosco's CQV priorities and the Instrumentation team's CSV activities.
• 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.

Key Responsibilities

• 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.
• Travel between Bend campus buildings as needed to support laboratory instrument and equipment qualification activities.
• Perform other duties as assigned.

Required Qualifications

Education: Bachelor's Degree in Engineering, Life Sciences, Chemistry, Biology, or a related scientific discipline preferred.

Experience

• Minimum 3-5 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.

Technical Knowledge

• Proven experience using Kneat validation/documentation software.
• Strong understanding of GMP documentation requirements and validation practices.

Knowledge of:

• 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.

Key Competencies

• Excellent technical writing and documentation skills.
• Strong organization and attention to detail.
• Ability to prioritize effectively across multiple projects and stakeholders.
• Proactive problem-solving skills.
• Ability to work both independently and collaboratively in a regulated environment.
• Strong communication and cross-functional collaboration skills.
• Commitment to quality, compliance, and data integrity.

Physical & Environmental Requirements

• Work within a clean, secure, and regulated GMP environment.
• Wear required PPE, including lab coats, safety glasses, gloves, and other protective equipment as required.
• Occasional lifting of up to 50 pounds.
• Travel between site buildings as needed.
• Flexible schedule to support project activities.