Commissioning & Qualification (C&Q) Lead
Location: Carolina, Puerto Rico
Work Arrangement: 100% Onsite for the duration of the project
Engagement: Contract, 6 months with extension expected (multi-year project)

About the Opportunity
Join a major site expansion at a pharmaceutical manufacturing facility in Puerto Rico. This is a long-term, multi-year capital program with a large, active portfolio of concurrent C&Q assignments. As C&Q Lead, you will own day-to-day execution and coordination of commissioning and qualification activities across your area of the project, partnering closely with construction, automation, vendors, and service providers.

Key Responsibilities

• Ensure adherence to C&Q procedures and program strategies, and continuously identify improvements in efficiency and compliance.
• Manage day-to-day service-provider C&Q execution: documentation preparation and status tracking, RV/IV generation, early (locked-data) review and disposition, and SGT/test-case creation and planning.
• Coordinate FATs with vendors and construction managers; track the FAT schedule and 4-week look-aheads.
• Review mechanical completion acceptance for systems.
• Coordinate pre-commissioning: priming utilities, instrument calibration, automation downloads, consumables installation (e.g., filter cartridges), and VFD setup.
• Coordinate punch list close-out with C&Q firms and the SWAT team.
• Support the C&Q schedule interface with the CQV scheduler: schedule changes, look-aheads, critical-path analysis.
• Support the construction-to-C&Q interface: turnover coordination, OAC status, and system/subsystem boundary changes on P&IDs affecting test-package scope.
• Support PIDCN log review and PICC determination; maintain a defensible PICC compliance assessment.
• Manage change management from initial scope through metrics, look-aheads, critical path, and resourcing; represent C&Q in governance forums.
• Support monthly sponsor reviews (progress, roadblocks, scope, staffing, funding status).
• Promote a strong safety culture across all C&Q activities.

Required Qualifications

• 5+ years of C&Q leadership on site expansion, brownfield, or greenfield projects
• Bachelor's degree in engineering, science, or a related field
• 10+ years of C&Q experience, preferably in pharmaceutical or biotech
• Prior WFI (Water for Injection) experience
• In-depth knowledge of regulatory requirements and industry standards for C&Q
• Strong leadership skills, able to oversee multiple C&Q activities and service providers at once
• Excellent analytical and problem-solving skills
• Strong written and verbal communication with program leadership and construction/service-provider interfaces
• Commitment to site safety standards

Preferred Qualifications

• Experience on mega capital expansion projects ($100M+)
• Familiarity with electronic qualification platforms (e.g., Kneat) and GMP documentation standards (21 CFR Part 11)
• Master's degree

Why This Role

• Large-scale, long-term expansion program with visibility and stability
• Lead a high-impact C&Q scope in a major pharmaceutical build-out
• Work across construction, automation, vendor, and senior program leadership teams
• Opportunity to extend with the project through its multi-year lifecycle

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.