CQV Engineer: GMP Equipment Qualification Specialist

Katalyst-Healthcares-; Fayetteville (NC); Sur place; USD 120 000 - 150 000; Plein temps

Résumé du poste

Katalyst-Healthcares- 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 and execute protocols, document results, address deviations, and ensure equipment readiness for manufacturing and engineering activities.

Qualifications

• Approximately 5-10 years of CQV experience in equipment validation or qualification.
• Strong hands-on experience executing IQ/OQ and other equipment qualification protocols.
• Experience in pharmaceutical, biotech, GMP manufacturing environments.

Responsabilités

• Hands-on execution of equipment commissioning and qualification activities.
• Review and execute established qualification protocols.
• Document test results and address discrepancies or deviations encountered during execution.
• Support equipment readiness for manufacturing and engineering activities.

Connaissances

CQV experience

IQ/OQ execution

GMP environment

Equipment qualification

Description du poste

Job Description:

• Seeking experienced Equipment CQV Engineers to support an onsite GMP equipment qualification program at a biopharmaceutical manufacturing facility.


• Consultants will be responsible for hands‑on execution of equipment commissioning and qualification activities, including reviewing and executing established qualification protocols, documenting test results, identifying and resolving execution issues, and supporting equipment readiness for manufacturing and engineering activities.


• The role will involve qualification of various manufacturing, laboratory, and support equipment in a regulated GMP environment.


• Candidates should be comfortable working independently, moving quickly through multiple equipment packages, and collaborating with Engineering, Validation, Manufacturing, Quality, and equipment vendors.

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.