CQV Validation Engineer: Aseptic Fill/Finish Expert

Katalyst CRO; Springfield (MA); On-site; USD 85,000 - 110,000; Full time

Job summary

Katalyst CRO in Springfield, MA is seeking Validation Engineers to support qualification work in sterile manufacturing. Ideal candidates will have extensive experience in CQV activities, including strong OQ and PQ execution skills. Responsibilities include hands-on work, documentation, and driving qualification deliverables.

Applicants should have a Bachelor's degree in Engineering or Life Sciences and must be able to work independently in a fast-paced environment focusing on fill/finish operations.

Qualifications

• Hands-on validation engineering or CQV experience.
• Strong OQ/PQ execution and documentation background.
• Fill/finish and aseptic filling experience.

Responsibilities

• Support upcoming qualification work tied to sterile manufacturing.
• Execute protocols accurately and document in real time.
• Drive qualification deliverables to completion.

Skills

Hands-on validation engineering or CQV experience

Strong OQ/PQ execution and documentation background

Fill/finish qualification experience

Experience with aseptic filling

GMP documentation experience

Ability to work independently in a fast-paced project environment

Education

Bachelor's degree in Engineering or Life Sciences

Tools

Kaye validators

Wireless probes

Job description

Katalyst CRO in Springfield, MA is seeking Validation Engineers to support qualification work in sterile manufacturing. Ideal candidates will have extensive experience in CQV activities, including strong OQ and PQ execution skills. Responsibilities include hands-on work, documentation, and driving qualification deliverables.

Applicants should have a Bachelor's degree in Engineering or Life Sciences and must be able to work independently in a fast-paced environment focusing on fill/finish operations.