GMP Equipment CQV Engineer — Onsite Validation Expert

JobDiva, Inc.; Boston (MA); On-site; USD 90,000 - 140,000; Full time

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 commissioning and qualification, review protocols, and document test results.

The role requires strong IQ/OQ execution, GMP documentation discipline, and the ability to work independently while collaborating with Engineering, Validation, Manufacturing, Quality, and vendors to ensure

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

• Execute equipment qualification activities and implement qualification protocols on site.
• Review and document test results, and address discrepancies or deviations.
• Collaborate with Engineering, Validation, Manufacturing, Quality, and equipment vendors to ensure readiness for manufacturing.
• Support equipment readiness for manufacturing and engineering activities.

Skills

IQ/OQ execution

Equipment qualification

GMP documentation

Independent work

Cross-functional collaboration

Job description

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 commissioning and qualification, review protocols, and document test results.

The role requires strong IQ/OQ execution, GMP documentation discipline, and the ability to work independently while collaborating with Engineering, Validation, Manufacturing, Quality, and vendors to ensure