Validation Engineer

Katalyst CRO; Springfield (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Katalyst CRO is seeking onsite Validation Engineers to support qualification work tied to sterile manufacturing and fill/finish operations. You will perform hands-on OQ/PQ execution, GMP documentation, protocol execution, and address discrepancies to drive qualification deliverables to completion.

The ideal candidate brings direct validation or CQV experience in GMP environments, with exposure to aseptic filling, sterilization equipment, and high-speed fill lines.

Qualifications

• Hands-on validation/CQV experience in GMP environments.
• Experience with aseptic fill/finish and sterile manufacturing.
• Strong OQ/PQ execution and rapid protocol documentation.

Responsibilities

• Perform onsite OQ/PQ execution for sterile manufacturing equipment.
• Develop and execute qualification protocols, document in real time.
• Support discrepancies/deviations and drive closeout of packages.

Skills

Hands-on validation

CQV experience

OQ/PQ execution

Documentation

Independent onsite work

Aseptic filling

Fill/finish

GMP documentation

Protocol execution

Deviation support

Education

Bachelor's degree in Engineering, Life Sciences, or related

Tools

Kaye validators

Wireless probes

Protocol execution tools

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.