Senior Project Manager – Life Sciences / Pharma Manufacturing
Location: Raleigh–Durham, NC (with regional travel as required)
Position Type: Full-Time
Position Overview
The Project Manager – Life Sciences is responsible for managing pharmaceutical manufacturing construction projects, with a focus on GMP interior fit-out, process utilities, and equipment integration. This role requires an understanding of how construction decisions impact manufacturing startup, CQV, and regulatory readiness.
The ideal candidate is a strong construction PM who is comfortable working in GMP environments, coordinating with Engineering, MSAT, QA, Facilities, and equipment vendors, and managing complex interfaces without assuming process design or validation responsibility.
Key Responsibilities
Project Delivery
- Manage life sciences projects from preconstruction through turnover
- Lead GMP interior fit-out, cleanroom construction, and support space build-out
- Coordinate installation of process equipment and critical utilities (WFI, clean steam, CIP/SIP, process gases)
- Develop and manage detailed construction schedules aligned with equipment delivery, FAT/SAT, and startup milestones
GMP & Process-Aware Execution
- Ensure construction activities support GMP compliance and clean construction practices
- Understand and manage construction interfaces that affect CQV, without owning validation
- Coordinate construction turnover packages to support IQ/OQ readiness
- Maintain strict material control, cleanliness, and documentation standards
Stakeholder Coordination
- Interface with client Engineering, MSAT, QA, Manufacturing, and Facilities teams
- Coordinate specialty contractors, equipment vendors, and OEM-aligned installers
- Participate in equipment installation planning, FAT/SAT coordination, and startup readiness meetings
Commercial & Contract Management
- Manage budgets, cost forecasting, and change management
- Lead subcontractor procurement and scope definition for GMP work
- Identify and mitigate project risks related to schedule, utilities, and equipment interfaces
Documentation & Turnover
- Ensure accurate as-builts, redlines, and turnover documentation
- Support smooth handoff from construction to commissioning and qualification
- Maintain documentation traceability appropriate for regulated environments
Required Qualifications
- Bachelor’s degree in Construction Management, Engineering, or related field (or equivalent experience)
- 7+ years of construction project management experience
- 3+ years of experience on pharmaceutical, biotech, or regulated life sciences projects
- Direct experience with:
- MEP and process utilities coordination
- Working knowledge of:
- CQV concepts (IQ/OQ/PQ)
- FAT and SAT coordination
- Clean construction protocols
Preferred Qualifications
- Experience managing:
- Process equipment installation
- WFI, clean steam, CIP/SIP systems
- Experience working with:
- MSAT teams
- Validation consultants
- Automation and controls integrators
- Background on:
- CDMO or commercial manufacturing projects
- Fast-track or retrofit projects in operating facilities
- Strong cross-functional communication skills
- Comfortable operating in regulated environments
- Detail-oriented with documentation discipline
- Proactive risk identification and mitigation
- Able to manage ambiguity and evolving scope
- Calm and credible in front of QA and Manufacturing teams