Validation Engineer

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

• Client is looking for onsite Validation Engineers / CQV Engineers to support upcoming qualification work tied to sterile manufacturing and fill/finish operations. The consultants will support hands-on OQ/PQ execution, GMP documentation, protocol execution, discrepancy/deviation support, and equipment qualification activities.
• The ideal candidate will have direct validation engineering or CQV experience in a fast-paced GMP environment, with strong exposure to fill line qualification, aseptic filling, sterile manufacturing equipment, and execution-heavy validation work. Equipment experience with autoclaves, formulation equipment, fill suites, high-velocity fillers, isolators, parts washers, tanks, and aseptic process systems is highly relevant.
• Experience with vision systems or automated inspection systems is a strong plus, especially for candidates who have worked around high-speed fill lines or aseptic manufacturing lines. Candidates should be able to work independently onsite, execute protocols accurately, document in real time, identify discrepancies, and help drive qualification deliverables through completion.

Job Description

• Client is looking for onsite Validation Engineers / CQV Engineers to support upcoming qualification work tied to sterile manufacturing and fill/finish operations. The consultants will support hands-on OQ/PQ execution, GMP documentation, protocol execution, discrepancy/deviation support, and equipment qualification activities.
• The ideal candidate will have direct validation engineering or CQV experience in a fast-paced GMP environment, with strong exposure to fill line qualification, aseptic filling, sterile manufacturing equipment, and execution-heavy validation work. Equipment experience with autoclaves, formulation equipment, fill suites, high-velocity fillers, isolators, parts washers, tanks, and aseptic process systems is highly relevant.
• Experience with vision systems or automated inspection systems is a strong plus, especially for candidates who have worked around high-speed fill lines or aseptic manufacturing lines. Candidates should be able to work independently onsite, execute protocols accurately, document in real time, identify discrepancies, and help drive qualification deliverables through completion.

Requirements:

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline preferred. Equivalent hands-on validation/CQV experience in GMP manufacturing environments can be considered.

Strong Plus Skills:

• Aseptic Fill/Finish Equipment Experience: Exposure to isolators, high-velocity fillers, formulation equipment, fill suites, parts washers, tanks, and autoclaves.
• Sterilization / Sterile Manufacturing Systems: Experience with SIP, VHP, autoclaves, and sterile equipment qualification.
• Vision / Inspection System Experience: Background with vision systems or automated inspection systems, especially tied to aseptic filling or high-speed manufacturing lines.
• Validation Tools / Execution Support: Experience using Kaye validators, wireless probes, and supporting hands-on protocol execution.
• Documentation & Closeout: Strong ability to document execution in real time, manage discrepancies, and support protocol package closeout.

Include Must Have:

• Hands-on validation engineering or CQV experience.
• Strong OQ/PQ execution and documentation background.
• Fill/finish, aseptic filling, or fill line qualification experience.
• Sterilization or sterile manufacturing equipment experience.
• GMP documentation experience.
• Protocol execution experience.
• Deviation/discrepancy support experience.
• Ability to work independently in a fast-paced project environment.
• Experience supporting equipment qualification in a regulated life sciences environment.