GMP Equipment CQV Engineer – Hands-On Validation

Creative Solutions Services, LLC

Knoxville (TN)

On-site

USD 95,000 - 125,000

Full time

6 days ago

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Job summary

Creative Solutions Services, LLC is seeking experienced Equipment CQV Engineers to support an onsite GMP equipment qualification program at a biopharmaceutical manufacturing facility. You will perform hands-on equipment commissioning and qualification, review protocols, document results, and resolve deviations to ensure readiness for manufacturing and engineering activities.

Candidates should have 5-10 years of CQV or related qualification experience, with strong IQ/OQ skills and GMP-regulated

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, document test results, and resolve issues.
Qualify various manufacturing, laboratory, and support equipment in a GMP environment.
Collaborate with Engineering, Validation, Manufacturing, Quality, and equipment vendors to ensure readiness.