Sr. Project Manager

Position Overview

We are seeking a Sr. Manager with 10-15 years of experience to lead and oversee complex Commissioning, Qualification, Validation (CQV), HVAC, facility, utility, and operational readiness initiatives within GMP-regulated life sciences environments. The ideal candidate will have extensive experience managing cross‑functional teams, driving commissioning and qualification programs for pharmaceutical manufacturing facilities, clean rooms, utilities, and support systems, and ensuring alignment with organizational goals, regulatory expectations, and client requirements.

This role requires strong leadership, deep technical expertise in HVAC systems, cleanroom environments, facility utilities, and risk‑based CQV methodologies, as well as the ability to manage multiple high‑visibility work streams from planning through execution, turnover, and operational readiness. The successful candidate will serve as a key leader in coordinating construction, engineering, automation, validation, quality, and operations teams to deliver compliant and efficient project execution.

• Travel to client sites may be required up to 100%, depending on project needs and client expectations.

• Provide strategic leadership and oversight for projects spanning HVAC systems, facility infrastructure, commissioning, qualification, validation, startup, and operational readiness.
• Lead overall C&Q execution strategy for assigned manufacturing areas, utilities, clean rooms, HVAC systems, and support systems within GMP-regulated facilities.
• Manage commissioning, qualification, validation, startup, and turnover activities from construction completion through operational readiness and handoff to operations.
• Lead HVAC project execution activities across pharmaceutical manufacturing, laboratory, utility, and support areas.
• Coordinate daily activities of CQV engineers, contractors, vendors, and third‑party service providers to ensure successful project execution.
• Develop and maintain integrated C&Q schedules aligned with construction, automation, startup, and manufacturing readiness milestones.
• Develop and manage project plans, schedules, budgets, resource strategies, and risk mitigation activities across multiple work streams.
• Coordinate HVAC, facility, utility, and CQV scope with construction, automation, facilities, manufacturing, quality, and engineering teams.
• Facilitate and lead system impact assessments, criticality assessments, boundary reviews, and turnover planning activities.
• Oversee cleanroom implementation including airflow design, pressurization cascades, environmental controls, and contamination control strategies to meet GMP requirements.
• Manage contractors, vendors, schedules, field execution activities, startup efforts, and punch list resolution through project completion.
• Drive HVAC startup, commissioning, qualification (IQ/OQ/PQ), validation, and operational readiness activities in alignment with project CQV strategies.
• Support Factory Acceptance Tests (FATs), Site Acceptance Tests (SATs), vendor startup activities, integrated system testing, and system readiness verification.
• Perform and lead field walkdowns, system inspections, field verification activities, and issue resolution for manufacturing, utility, HVAC, and facility systems.
• Review and approve commissioning and qualification documentation including Commissioning Plans, Commissioning Test Plans (CTPs), Commissioning Test Records, IQ/OQ/PQ Protocols, Summary Reports, Turnover Packages, ETOP Documentation, and associated startup documentation.
• Ensure delivery of key milestones, commissioning deliverables, validation packages, and turnover documentation.
• Guide development and execution of commissioning plans, qualification protocols, validation strategies, and turnover packages.
• Partner with Quality, Validation, Engineering, and Operations organizations to ensure compliance with corporate standards, GMP requirements, and regulatory expectations.
• Support risk assessments, change controls, deviations, CAPAs, investigations, and readiness reviews.
• Drive issue resolution, action item management, and punch list closure to support timely…