CQV Engineer: GMP Equipment Qualification Specialist

Creative Solutions Services, LLC

Fayetteville (AR)

On-site

USD 90,000 - 130,000

Full time

10 days ago

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Job summary

Creative Solutions Services, LLC seeks 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 and execute qualification protocols, document results, and address issues to ensure equipment readiness.

Candidates should have 5–10 years in CQV or similar, strong IQ/OQ experience, GMP-regulated manufacturing background, and the

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 IQ/OQ and other equipment qualification protocols.
Document test results and resolve execution issues.
Support equipment readiness for manufacturing and engineering activities.
Collaborate with Engineering, Validation, Manufacturing, Quality, and equipment vendors.