CQV Engineer

Pioneer GMP Consulting • Cambridge/Boston, MA

1d • Onsite

About The Position

Pioneer GMP Consulting is seeking a Mid-Level CQV Engineer to support commissioning, qualification, and validation activities for pharmaceutical and biotech manufacturing projects in the Cambridge/Boston area. This onsite role will support GMP facilities, utilities, equipment, and manufacturing systems through the full project lifecycle, from startup and commissioning through qualification and validation execution. The ideal candidate has hands-on CQV experience within GMP-regulated environments and is comfortable working cross-functionally with Engineering, Manufacturing, Quality, and project teams in fast-paced client environments.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or related technical discipline
• 3–7 years of CQV experience within the pharmaceutical, biotech, or life sciences industry
• Experience supporting GMP manufacturing environments
• Strong working knowledge of cGMPs, FDA regulations, ISPE guidelines, and validation lifecycle principles
• Experience with one or more of the following: Process equipment qualification, Clean utilities, HVAC systems, Facilities commissioning, Automation systems, Process validation
• Ability to work onsite in the Cambridge/Boston area
• Strong technical writing and documentation skills
• Excellent communication and collaboration skills

Nice To Haves

• Experience supporting large capital projects or facility expansions
• Experience in biologics, cell & gene therapy, or aseptic manufacturing environments
• Familiarity with Kneat, ValGenesis, Blue Mountain, or other validation systems
• Ability to manage multiple projects and priorities simultaneously

Responsibilities

• Execute commissioning, qualification, and validation activities for GMP facilities, utilities, equipment, and systems
• Develop and execute IQ/OQ/PQ protocols and associated documentation
• Support commissioning and startup activities for manufacturing equipment and process systems
• Review and approve turnover packages, test documentation, and vendor documentation
• Coordinate with Engineering, Quality Assurance, Manufacturing, and Automation teams to ensure project deliverables are completed on schedule
• Perform field verification, walkdowns, and discrepancy resolution
• Support deviation investigations, change controls, and CAPA activities as needed
• Ensure compliance with FDA, cGMP, GAMP, and client-specific quality standards
• Participate in risk assessments and system impact assessments
• Maintain accurate project documentation and validation traceability throughout the project lifecycle

Benefits

• Technical excellence
• Accountability and ownership
• Collaborative problem-solving
• Professional growth and development
• Building strong client partnerships

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level