Senior Validation Engineer (CSV/CQV) - Onsite Bend, OR

Naderi Engineering, Inc.; Bend (OR); On-site; USD 90,000 - 130,000; Full time

Job summary

Lonza is seeking a contractor-level CSV/CQV Specialist to support a backlog of qualification and validation activities in a regulated cGMP environment. Onsite presence in Bend, Oregon is required to support instrument qualification and GMP equipment activities.

The role will collaborate with Instrumentation and CQV teams, manage multiple priorities, and produce high-quality documentation while hands-on with laboratory instruments. Requires experience with IQ/OQ/PQ and 21 CFR Part 11 compliance.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Chemistry, Biology, or related field.
• 3–5 years of CQV/CSV experience in regulated industries.
• Experience in cGMP environments.
• Experience with computerized systems validation.

Responsibilities

• Develop, execute, review, and maintain validation lifecycle documentation (URS, Design Specs, Traceability Matrices, Test Scripts, Validation Protocols).
• Support IQ/OQ/PQ activities for analytical instruments, computerized systems, and GMP equipment.
• Ensure data integrity and 21 CFR Part 11/Annex 11 compliance in all validation activities.
• Collaborate with QC, Instrumentation, Engineering, Automation, QA to plan and execute validation.
• Prepare and support change controls, deviations, CAPAs, and validation protocols.
• Maintain inspection-ready documentation per SOPs and GxP requirements.
• Travel between Bend campus buildings to support qualification activities.

Skills

CSV/CSV

CQV

Analytical instruments

Technical writing

Cross-functional collaboration

GxP knowledge

Documentation control

Kneat platform

Education

Bachelor's degree in Engineering/Life Sciences/C Chemistry/ Biology

Tools

Kneat

Job description

Lonza is seeking a contractor-level CSV/CQV Specialist to support a backlog of qualification and validation activities in a regulated cGMP environment. Onsite presence in Bend, Oregon is required to support instrument qualification and GMP equipment activities.

The role will collaborate with Instrumentation and CQV teams, manage multiple priorities, and produce high-quality documentation while hands-on with laboratory instruments. Requires experience with IQ/OQ/PQ and 21 CFR Part 11 compliance.