GMP Equipment CQV Engineer - Hands-On Validation Lead

Katalyst CRO

Boston (MA)

In loco

USD 120.000 - 180.000

Tempo pieno

14 giorni+

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Descrizione del lavoro

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.

Competenze

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.

Mansioni

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.