CQV Validation Engineer - CSV & Instrument Systems

Katalyst CRO; Bend (OR); In loco; USD 90.000 - 130.000; Tempo pieno

Descrizione del lavoro

Katalyst CRO in Bend, Oregon is seeking a contractor-level CSV/CQV Specialist to support validation activities for analytical instruments, computerized systems, and GMP equipment in a regulated cGMP environment. This role requires onsite presence in Bend and collaboration with CQV and Instrumentation teams.

Responsibilities include developing validation documentation, executing IQ/OQ/PQ, data integrity, and ensuring 21 CFR Part 11 compliance, while coordinating with Quality Control, Engineering,

Competenze

• Bachelor's degree in engineering, Life Sciences, Chemistry, Biology or a related scientific discipline preferred.
• Experience with validation of analytical laboratory instruments and equipment in regulated environments.
• Strong documentation and technical-writing skills.

Mansioni

• Develop, execute, review, and maintain validation lifecycle documentation (e.g., URS, Design Specs, IQ/OQ/PQ).
• Support validation activities for new and existing analytical instruments, computerized systems, and GMP equipment.
• Coordinate with CQV, Instrumentation, QC, Engineering, QA and system owners to plan and execute validation activities.
• Prepare change controls, deviations, CAPAs, and validation protocols related to GMP equipment and instruments.
• Utilize Kneat platform for document creation, routing, approvals, and record closure.
• Maintain inspection-ready documentation in accordance with SOPs and GxP requirements.
• Travel between Bend campus buildings to support qualification activities.

Conoscenze

Kneat validation

CSV/CSV

GxP

21 CFR Part 11

CQV validation

Formazione

Bachelor's degree in engineering

Bachelor's degree in Life Sciences

Strumenti

Kneat Validation Software

Descrizione del lavoro

Katalyst CRO in Bend, Oregon is seeking a contractor-level CSV/CQV Specialist to support validation activities for analytical instruments, computerized systems, and GMP equipment in a regulated cGMP environment. This role requires onsite presence in Bend and collaboration with CQV and Instrumentation teams.

Responsibilities include developing validation documentation, executing IQ/OQ/PQ, data integrity, and ensuring 21 CFR Part 11 compliance, while coordinating with Quality Control, Engineering,