Equipment CQV Engineer

Stark Pharma Solutions Inc; Boston (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Stark Pharma Solutions Inc in Boston (MA) is seeking experienced Equipment CQV Engineers to support an onsite GMP equipment qualification program at a biopharmaceutical manufacturing facility. The role focuses on hands-on CQV execution and qualification across manufacturing and lab environments.

You will review and execute IQ/OQ protocols, document results, and address discrepancies, partnering with Engineering, Validation, Manufacturing, Quality, and vendors.

Qualifications

• Minimum 5–10 years of CQV or equipment qualification experience.
• Hands-on IQ/OQ execution in GMP environments.

Responsibilities

• Review and execute IQ/OQ protocols.
• Document test results and resolve issues.
• Support readiness of equipment for manufacturing and engineering activities.
• Qualify various manufacturing, lab and support equipment.
• Collaborate with Engineering, Validation, Manufacturing, Quality and vendors.
• Work independently, moving quickly through multiple equipment packages.

Skills

IQ/OQ execution

GMP documentation

Equipment qualification

Pharma manufacturing

Team collaboration

Job description

Role

Seeking experienced Equipment CQV Engineers to support an onsite GMP equipment qualification program at a biopharmaceutical manufacturing facility. The role focuses on hands‑on execution of equipment commissioning and qualification activities across manufacturing, laboratory, and support of equipment in a regulated GMP environment.

Equipment CQV Engineer

Role

Seeking experienced Equipment CQV Engineers to support an onsite GMP equipment qualification program at a biopharmaceutical manufacturing facility. The role focuses on hands‑on execution of equipment commissioning and qualification activities across manufacturing, laboratory, and support of equipment in a regulated GMP environment.

Key Responsibilities

• Review and execute established equipment qualification protocols (IQ/OQ).
• Document test results and identify/resolve execution issues.
• Support equipment readiness for manufacturing and engineering activities.
• Qualify various manufacturing, laboratory, and support equipment.
• Partner with Engineering, Validation, Manufacturing, Quality, and equipment vendors.
• Work independently, moving quickly through multiple equipment packages.

Required

• 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 for manufacturing and/or laboratory equipment.
• Ability to review protocols, execute testing, document results, and address discrepancies/deviations.
• Understanding GMP documentation and good documentation practices.