Equipment CQV Engineer

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

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.