Pharmaceutical Project Manager
Core
Day-to-day project lead for validated environment and laboratory construction projects (e.g., cleanrooms, biosafety cabinets, containment suites) across a campus, ensuring operational excellence, compliance, and financial performance.
Role type
Senior IC pharmaceutical project manager (validated environments)
Builds
Validated-state laboratory and cleanroom facilities for biopharma, medical devices, and healthcare clients
Domain
Life sciences construction and facility validation
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Project management in regulated settings, validation strategy development, cross-functional team coordination, risk mitigation, contract administration, budget management, regulatory compliance knowledge, stakeholder management, vendor management
Preferred skills
Master's degree, PMP certification, CQV/CSV experience, FDA 21 CFR Part 11/EU Annex 11 knowledge, cleanroom construction experience, datacenter-adjacent facility experience
Technologies
Primavera P6, MS Project, Solution Navigator
Responsibilities
Plan, execute, monitor, and close validated environment projects ensuring IQ/OQ/PQ and data integrity; Coordinate Owners, Architects, Engineers, QA/Validation, Contractors, and Vendors; Define and maintain project scope, schedule, and budget baselines; Develop and implement validation strategies and documentation; Identify, assess, and mitigate project-level risks; Track and report project performance to the Project Executive; Manage change orders, procurement, and contract administration; Ensure robust documentation controls for regulatory inspections; Manage vendor and subcontractor performance; Manage project finances including budgeting and forecasting; Prepare the project team for regulatory inspections and audits.
Seniority
Senior, hands-on IC with potential supervision of coordinators