Pharmaceutical Project Manager

Summary

This role is the day-to-day project lead for validated environment and laboratory construction projects (e.g., cleanrooms, biosafety cabinets, containment suites, biocontainment labs, and related utilities) across a campus. The Project Manager will report to the Project Executive and partner with Engineering, QA/Validation, Delivery, Sponsors, and regional leadership to deliver projects within a validated-state framework, focusing on operational excellence, compliance, and both tactical and financial performance.

What will you do

Plan, execute, monitor, and close validated environment projects across multiple sites, ensuring IQ/OQ/PQ, equipment qualification, data integrity, and regulatory expectations are met. Serve as the on-site/day-to-day on-site project lead, coordinating Owners, Architects, Engineers, QA/Validation, Contractors, and Vendors to achieve project objectives within validated-state constraints. Collaborate with the Project Executive to define and maintain project scope, schedule, and budget baselines; monitor progress and report deviations. Drive project schedule with a sense of urgency while not compromising quality. Develop and implement validation strategies and documentation (validation plans, commissioning/qualification activities, and related records) aligned with corporate validation policy. Identify, assess, and mitigate project-level risks that could impact deliverables, schedules, budgets, data integrity, or compliance; escalate as needed with proposed remedies. Track and report project performance to the Project Executive, including schedule status, budget, risk, QA/validation progress, and regulatory readiness. Manage and appropriately change orders, project delays, procurement, and contract administration for assigned projects; ensure alignment with validated baselines and contract requirements. Update all logs on at least a weekly basis. Manage all documentation as per standards in Solution Navigator. Ensure robust documentation controls that meet contract, QA, and regulatory standards (validation protocols, IQ/OQ/PQ records, SOP alignment, QA approvals) and support regulatory inspections. Seek opportunities to improve validation workflows, data integrity practices, and delivery quality to enhance client satisfaction. Maintain relationships with sponsors and stakeholders; act as a trusted advisor on validated-environment delivery and compliance at the project level. Manage vendor and subcontractor performance for assigned projects, selecting qualified partners and ensuring alignment with timelines and objectives. Manage project finances at the assignment level, including budgeting, forecasting, progress billings, and payables, ensuring alignment with project baselines. Prepare the project team for regulatory inspections and audits through thorough documentation and traceability. Foster a safe, compliant, and collaborative project environment; provide guidance to junior team members as needed.

What you will need to be successful (Required)

Bachelor’s degree in construction, Civil, Mechanical, Electrical Engineering, Construction Management, Business Management, Architecture, or a related field. 5–10 years of direct project management experience on large capital projects, including regulated or validated settings (typical project sizes in the $5–$20M range; portfolio responsibility not required). Demonstrated success delivering complex, multi-site projects in validated environments (GMP/GLP/ISO 17025) within labs, biopharma, pharmaceutical manufacturing, medical devices, healthcare, or related sectors. Understanding of contract language, project accounting, and basic portfolio management as they apply to validated environments. Strong executive communication skills; ability to present to senior leadership and diverse stakeholder groups; capable of influencing across functional boundaries. Ability to lead and coordinate cross-functional teams (Owners, Architects, Engineers, QA/Validation, Contractors) in regulated contexts. Proficiency with standard project management tools (Primavera P6, MS Project) and reporting platforms; advanced skills in MS Office with the ability to create executive-level dashboards and presentations. Working knowledge of validation concepts, commissioning/qualification processes, data integrity best practices, and regulatory expectations for validated facilities. Ability to establish and maintain professional relationships with key stakeholders and subcontractors in validated environments. Willingness to travel and operate across multiple sites as needed.

Preferred

Master’s degree. PMI certification (PMP) or equivalent. Certifications or hands-on experience in CQV; CSV awareness; familiarity with FDA 21 CFR Part 11, EU Annex 11, and related regulatory frameworks. Specific experience delivering validated environments: GMP/GLP labs, ISO 14644 cleanrooms, ISO 17025 laboratories, or similar. Experience working on programs in datacenter-adjacent facilities requiring stringent validation regimes. Demonstrated ability to contribute to continuous improvement programs for validation processes and data integrity across a project portfolio.

Reporting line

This position reports to the Project Executive. May supervise project coordinators or junior project team members as part of the assigned project team.

Salary and benefits

HIRING SALARY RANGE: $130,000.00 - 165,000.00 USD Annual. (Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data.) This position includes a competitive benefits package.

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