Validation Engineer 2 - Onsite CSV/CQV Specialist (Contract)

Planet Pharma; Bend (OR); On-site; USD 117,000 - 128,000; Full time

Job summary

Planet Pharma in Bend, Oregon is seeking a contractor-level CSV/CQV Specialist to support a high-priority backlog of qualification and validation activities for analytical instruments, computerized systems, and GMP equipment.

You will split time between CQV priorities and Instrumentation CSV activities, managing multiple priorities, producing high-quality documentation, and working hands-on in a regulated cGMP environment on-site in Bend.

Qualifications

• Bachelor’s degree in engineering, life sciences, chemistry, biology, or related field preferred.
• 3–5 years CQV/CSV experience in regulated industries.
• Experience with computerized systems validation and equipment qualification.
• Experience in cGMP environments and document-heavy validation.

Responsibilities

• Develop, review, and maintain validation lifecycle documents (URS, Design Specs, IQ/OQ/PQ, TRMs, test scripts, reports).
• Support qualification/validation for analytical instruments, computerized systems, and GMP equipment.
• Execute IQ/OQ/PQ activities and ensure 21 CFR Part 11/Annex 11 compliance.
• Collaborate with Quality, Instrumentation, Engineering, and QA teams to plan validation activities.
• Prepare change controls, deviations, CAPAs, and validation protocols; manage Kneat templates.

Skills

Validation

CSV

CQV

GxP knowledge

Technical writing

Project coordination

Cross-functional teamwork

Education

Bachelor’s Degree in Engineering

Tools

Kneat

Job description

Planet Pharma in Bend, Oregon is seeking a contractor-level CSV/CQV Specialist to support a high-priority backlog of qualification and validation activities for analytical instruments, computerized systems, and GMP equipment.

You will split time between CQV priorities and Instrumentation CSV activities, managing multiple priorities, producing high-quality documentation, and working hands-on in a regulated cGMP environment on-site in Bend.