CQV Engineer: GMP Equipment Qualification Specialist

Katalyst-Healthcares-; Fayetteville (AR); Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

CQV

IQ/OQ

GMP

Equipment qualification

Documentation

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.