GMP Equipment CQV Engineer — Hands-On Qualification

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

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.