Equipment Engineer — Commissioning and Qualification

Job overview

The Equipment Engineer — Commissioning and Qualification role is onsite in Fairview, OR. Compensation is not specified. The role supports equipment, instruments, facilities, and utilities in a GMP-regulated pharmaceutical environment. The engineer helps implement, commission, qualify, and maintain equipment in a validated and compliant state. By developing protocols and documentation, supporting projects and maintenance, and providing technical guidance, the role contributes to reliable operations and regulatory compliance.

What you'll do

• Maintain commissioned and qualified equipment, facilities, and utilities
• develop commissioning and qualification protocols and reports
• supervise vendors performing qualification activities
• support operational procedures and validation
• execute qualification and validation protocols
• prepare validation plans, specifications, traceability matrices, and reports
• support change management and equipment implementation projects
• support calibration and preventive maintenance
• complete compliant documentation
• respond to qualification requests
• provide technical guidance
• participate in deviation investigations as a subject matter expert when required.

What we're looking for

Skills & competencies

equipment engineer

fairview or

katalyst healthcares & life sciences

equipment qualification

commissioning

validation

gmp

pharmaceutical manufacturing

facilities and utilities

cgmp

gxp

gamp

21 cfr part 11

change management

Work arrangement

• Weekend coverage required

Why this role

The posting prefers a bachelor’s degree in engineering or science, or equivalent relevant experience; requires at least five years in a GMP environment and three years in equipment, facilities, or utilities qualification. Knowledge of cGMP, GxP, GAMP, SDLC, 21 CFR Part 11, and CSV is listed.

About the employer

Katalyst Healthcares & Life Sciences is hiring for this role. Industry: Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). Sector: 54.