What are the responsibilities and job description for the Lead CQV Engineer / Lead Validation Engineer position at Grove Technical Resources?
Hiring: Lead CQV Engineer / Lead Validation Engineer
Location: Devens, MA (100% Onsite)
Pharmaceutical / Biologics / Cell Therapy Industry
We are seeking an experienced Lead CQV Engineer / CQV Project Manager to lead commissioning, qualification, and validation activities for GMP manufacturing projects.
Key Skills:
Commissioning, Qualification & Validation (CQV)
Equipment Qualification (IQ/OQ/PQ)
GMP Compliance & Validation Strategy
Protocol Development & Technical Review
Deviation Management & Change Control
CQV Project Leadership.
Responsibilities:
Lead CQV execution strategy and qualification activities for GMP equipment
Develop and review URS, IQ/OQ/PQ protocols, readiness checklists, and qualification reports
Provide technical oversight for validation deliverables and execution teams
Drive deviation investigations, discrepancy resolution, and change control activities
Collaborate with Engineering, Quality, Operations, and Vendor teams to ensure project success
Support GMP readiness, capacity expansion, and project milestone delivery.
Preferred Qualifications:
10 years of CQV / Validation experience in Pharmaceutical, Biologics, Cell Therapy, or Life Sciences environments
Experience as a CQV Lead, Validation Lead, or CQV Project Manager
Strong background in equipment qualification, protocol execution, and GMP documentation
Experience with ValGenesis and large-scale validation programs
Biologics or Cell Therapy manufacturing experience preferred.
📅 Immediate Opportunity
🏢 Full-Time Onsite – Devens, MA.
Interested candidates, please share your updated resume.