Onsite Validation Engineer - Sterile Fill/Finish CQV

Katalyst CRO; Tucson (AZ); On-site; USD 90,000 - 135,000; Full time

Job summary

Katalyst CRO is seeking onsite Validation Engineers / CQV Engineers to support qualification work in sterile manufacturing and fill/finish operations. You will perform hands-on OQ/PQ execution, GMP documentation, and protocol execution while addressing discrepancies and supporting equipment qualification.

The ideal candidate has validation/CQV experience in a fast-paced GMP setting with exposure to aseptic filling, sterilization, and high-speed lines.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related technical discipline preferred.
• Equivalent hands-on validation/CQV experience in GMP manufacturing environments can be considered.
• Strong exposure to fill line qualification, aseptic filling, and sterile manufacturing equipment is highly relevant.

Responsibilities

• Support hands-on OQ/PQ execution and GMP documentation.
• Execute protocols accurately and document in real time.
• Identify discrepancies and help drive qualification deliverables through completion.
• Work independently onsite in a fast-paced project environment.

Skills

Hands-on validation

CQV experience

GMP documentation

OQ/PQ execution

Aseptic qualification

Fill/finish equipment

Vision/inspection systems

Equipment qualification

Discrepancy support

Real-time documentation

Education

Bachelor's degree in Engineering

Bachelor's degree in Life Sciences

Tools

Kaye validators

Wireless probes

Job description

Katalyst CRO is seeking onsite Validation Engineers / CQV Engineers to support qualification work in sterile manufacturing and fill/finish operations. You will perform hands-on OQ/PQ execution, GMP documentation, and protocol execution while addressing discrepancies and supporting equipment qualification.

The ideal candidate has validation/CQV experience in a fast-paced GMP setting with exposure to aseptic filling, sterilization, and high-speed lines.