GMP Equipment CQV Engineer - Hands-On Validation Lead

Katalyst CRO; Boston (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

Katalyst CRO is seeking experienced Equipment CQV Engineers to support an onsite GMP equipment qualification program at a biopharmaceutical manufacturing facility. Consultants will perform hands-on commissioning and qualification activities, review protocols, document results, and help ensure equipment readiness for manufacturing and engineering activities.

The role covers qualification of manufacturing, laboratory, and support equipment in a regulated GMP environment.

Qualifications

• Approximately 5–10 years of CQV, equipment validation, or equipment qualification experience.
• Strong hands-on experience executing IQ/OQ and other equipment qualification protocols.
• Pharmaceutical, biotechnology, biopharmaceutical, cell therapy, or other GMP-regulated manufacturing experience.
• Experience qualifying manufacturing and/or laboratory equipment.
• Ability to review protocols, execute testing, document results, and address discrepancies or deviations encountered during execution.
• Understanding of GMP documentation and good documentation practices.

Responsibilities

• Hands-on execution of equipment commissioning and qualification activities.
• Review and execute established qualification protocols and document test results.
• Identify and resolve execution issues and support equipment readiness for manufacturing and engineering activities.
• Collaborate with Engineering, Validation, Manufacturing, Quality, and equipment vendors.

Skills

CQV experience

IQ/OQ execution

GMP documentation practices

Independent working

Tools

IQ/OQ protocols

Job description

Katalyst CRO is seeking experienced Equipment CQV Engineers to support an onsite GMP equipment qualification program at a biopharmaceutical manufacturing facility. Consultants will perform hands-on commissioning and qualification activities, review protocols, document results, and help ensure equipment readiness for manufacturing and engineering activities.

The role covers qualification of manufacturing, laboratory, and support equipment in a regulated GMP environment.