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 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 at least weekly. 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.
Benefits
- Competitive base salary and a comprehensive bonus program.
- Three weeks paid vacation , holidays, sick time, and 3 PTO days in a calendar year.
- Comprehensive benefits package including 401K, medical, dental, and vision care – available day one.
- Extensive product and cross training opportunities .
- Encouraging and collaborative team environment .
- Dedication to safety through Zero Harm policy .
- Providing scheduling and management support .
- JCI Employee discount programs (The Loop by Perk Spot).
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