Senior Project Manager

Position Overview
Senior Project Manager
Responsible for the end-to-end delivery of life sciences capital projects, including GxP facility renovations (minor and major), new laboratory/manufacturing builds, and critical utility infrastructure upgrades. This role ensures all projects maintain a "state of control" and meet stringent regulatory requirements.
Essential Requirements
Education & Certifications

• Bachelor’s degree in Engineering (Mechanical, Chemical, or Civil), Construction Management, Architecture, or a related scientific field.
• PMP (Project Management Professional) certification required.
• ISPE (International Society for Pharmaceutical Engineering) membership or LEED AP certification is highly advantageous.

Experience

• 7–10 years of project management experience in complex technical construction.
• 5+ years of specific experience in Life Sciences, Biotech, or Pharmaceutical environments.
• Proven track record managing GMP facility capital projects ($1M–$25M+), including cleanroom build-outs (ISO 5–8), laboratory renovations, and critical infrastructure (validated HVAC, WFI/RO high-purity water, and EMS).
• Expertise in overseeing the technical integration of manufacturing skids, analytical instrumentation, and specialized containment areas (e.g., BSL-2/3).
• Deep understanding of FDA (21 CFR Part 211) and EMA regulatory requirements.
• Experience interfacing with local authorities, including zoning and specialized fire/safety code officials for hazardous material storage.

Technical Competencies
Project Management & Validation

• Validation & Commissioning: Mastery of the V-Model approach, including IQ/OQ/PQ protocols and Turnover Packages (TOP).
• Quality Management Systems (QMS): Direct experience managing Change Controls, Deviations, and CAPAs within a regulated project lifecycle.
• Scheduling & Cost Control: Proficiency in MS Project or Primavera P6; expertise in budget forecasting and mitigating "scope creep" in highly regulated environments.
• Risk Management: Ability to perform FMEA (Failure Mode and Effects Analysis) to protect product integrity during construction.

Technical Knowledge & Compliance

• Cleanroom Standards: In-depth knowledge of ISO 14644 standards and Grade A–D operational requirements.
• Operational Workflows: Understanding of unidirectional flow for personnel, material, and waste to prevent cross-contamination.
• Technical Skills: Proficiency in BIM/VDC platforms (Autodesk Construction Cloud, Procore) and document control for audit-ready project files.

Core Competencies
Leadership & Communication

• Cross-Functional Leadership: Ability to lead teams of MEP engineers, Validation specialists, QA/QC officers, and Architects of Record.
• Executive Presence: Ability to present project risks and financial health to C-suite stakeholders and Steering Committees.
• Conflict Resolution: Skill in negotiating with specialized sub-contractors and vendors (e.g., orbital welders, cleanroom panel installers).

Analytical & Problem-Solving

• Critical Decision Making: Ability to assess if a construction delay or field change impacts the validated state of the facility.
• Process Improvement: Applying "Lean Construction" or specialized methodologies to minimize downtime during facility shutdowns.

Preferred Qualifications

• Experience with Brownfield projects (renovating active GMP facilities without interrupting production).
• Familiarity with Digital Plant initiatives (Smart Buildings, IoT sensors for monitoring, and Lab Automation).

Key Performance Indicators (KPIs)

• On-Time Delivery: Target 95%+ (aligned with manufacturing production schedules).
• Budget Adherence: 100% within approved budget, including management of contingency.
• Validation Success Rate: Zero "Major" findings during Quality/Regulatory audits of project files.
• Safety Record: Zero lost-time incidents; 100% compliance with site-specific EHS protocols.
• Quality Metrics: Successful transition from "Mechanical Completion" to "Operational Readiness" with minimal punch-list items.