C&Q Lead Engineer

VM Associates is a trusted provider of comprehensive human resource solutions and specialized staffing services for the Pharmaceutical and Manufacturing industries across North America. With a focus on regulated environments, we connect companies with skilled professionals who excel in supporting compliance, innovation, and operational success. Our tailored solutions include contract staffing, direct hires, and project-based support, empowering businesses to meet their distinct goals with reliable talent.

Dedicated to serving diverse workforce needs, we are committed to fostering excellence in every partnership.

We are looking for a seasoned and highly accomplished Commissioning & Qualification (C&Q) Lead to own and drive all C&Q activities for a major capital expansion project involving the installation of multiple new packaging lines. This is a senior leadership role embedded within a pharmaceutical secondary and tertiary packaging operation for final drug product. You will serve as the technical authority for all things C&Q on this project leading, mentoring, and directing a team of C&Q engineers while remaining hands-on and present on the manufacturing floor where the work gets done.

We are looking for a true C&Q expert who has spent a career commissioning and qualifying equipment in pharmaceutical manufacturing environments, understands manufacturing processes and packaging equipment at a deep level, and knows how to build and lead high-performing teams through complex, fast-paced capital projects.

• Own and lead all commissioning and qualification activities across multiple new packaging line installations, from project kickoff through system turnover and handover to GMP operations
• Build, lead, mentor, and direct a team of C&Q engineers, establishing clear roles, responsibilities, and expectations across the team
• Serve as the C&Q technical authority for the project — setting standards, reviewing and approving documentation, and ensuring consistency and quality across all C&Q deliverables
• Develop and maintain the overall C&Q strategy, master plan, and schedule in alignment with project milestones and site requirements
• Perform and oversee hands‑on commissioning activities including equipment walkdowns, system verifications, punch list management, and SAT execution
• Actively participate on the floor alongside the C&Q team — this is a lead‑from‑the‑front role requiring direct engagement with equipment, vendors, and operations
• Partner closely with the Project Manager to align C&Q schedule and resource planning with overall project timelines, dependencies, and critical path
• Collaborate with equipment vendors, engineering, construction, Quality, and Operations to ensure systems are commissioned to specification and ready for GMP handover
• Identify, document, and drive resolution of commissioning discrepancies, open items, and deviations through to closure
• Ensure all C&Q activities are executed in full compliance with FDA, GMP, and applicable site and regulatory standards
• Maintain accurate, complete, and audit‑ready C&Q documentation in compliance with data integrity and site documentation requirements
• Support site leadership with C&Q status reporting, risk identification, and escalation as needed
• Apply deep manufacturing process and packaging equipment knowledge to ensure commissioning scope, test approaches, and acceptance criteria are grounded in real operational requirements

• Approximately 11‑25 years of experience in Commissioning & Qualification within pharmaceutical manufacturing — this is a C&Q role, not a validation role, and candidates from purely validation‑focused backgrounds will not be considered
• Pharmaceutical industry experience is required; candidates without pharma experience will not be considered
• Demonstrated experience leading and mentoring C&Q teams on medium to large capital projects in a regulated pharmaceutical environment
• Deep, hands‑on knowledge of manufacturing processes, packaging environments, and packaging equipment — candidates who have spent time on the floor and understand how equipment operates in a live manufacturing…