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.
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.
