Senior CQV Engineer: Lead GMP Validation & Commissioning

JobDiva, Inc.; Montpelier (VT); On-site; USD 130,000 - 180,000; Full time

Job summary

Creative Solutions Services, LLC is seeking an experienced Senior CQV Engineer to lead and execute commissioning, qualification, and validation activities for pharmaceutical manufacturing facilities. You will support equipment, utilities, facilities, and systems while ensuring compliance with GMP, FDA, GxP, and ISPE standards.

You will mentor junior CQV engineers and collaborate across Engineering, Quality, and project teams.

Qualifications

• Bachelor’s degree in a related engineering discipline.
• 7–10+ years of CQV/validation experience in regulated industries.
• Strong GMP/GxP validation knowledge.
• Excellent technical writing and leadership skills.

Responsibilities

• Lead CQV activities for equipment, utilities, facilities, and systems.
• Develop and execute URS, DQ, FAT, SAT, IQ, OQ, and PQ protocols.
• Review drawings, P&IDs, and vendor documentation.
• Coordinate FAT/SAT with vendors and project teams.
• Manage deviations, change controls, and CAPAs.
• Provide technical leadership and mentoring to junior CQV engineers.
• Ensure compliance with GMP/GxP, FDA, EU GMP, GAMP 5, ISPE.

Skills

CQV/validation

Technical writing

Leadership

Problem-solving

GMP/GxP knowledge

Education

Engineering degree

Job description

Creative Solutions Services, LLC is seeking an experienced Senior CQV Engineer to lead and execute commissioning, qualification, and validation activities for pharmaceutical manufacturing facilities. You will support equipment, utilities, facilities, and systems while ensuring compliance with GMP, FDA, GxP, and ISPE standards.

You will mentor junior CQV engineers and collaborate across Engineering, Quality, and project teams.