Senior Project Manager - GMP Projects

Job Title: Sr. Project Manager

Department: Project Management 

Location: 4 Sunshine Blvd, Ormond Beach, FL 32174 

Work Schedule: Full time, in a production environment 

Position Summary: Germfree is seeking a technically grounded Project Manager with a strong engineering foundation and demonstrated experience in regulated life sciences environments (GMP, FDA, ISO). This role will lead complex, multi-disciplinary projects involving the design, fabrication, and deployment of controlled environment solutions (e.g., cleanrooms, mobile labs, biocontainment equipment). The ideal candidate operates at the intersection of engineering rigor, regulatory compliance, and execution discipline, capable of driving projects from concept through validation and delivery while ensuring adherence to quality, cost, and schedule commitments.

Core Responsibilities

Project Leadership & Execution

• Lead end-to-end project execution (initiation through commissioning and closeout)
• Develop and manage integrated project plans, schedules, budgets, and resource allocations
• Drive cross-functional coordination across engineering, manufacturing, quality, supply chain, and field teams
• Lead and support equipment-focused projects, including isolators, containment systems, and other critical GMP processing equipment, from design through FAT/SAT and final commissioning
• Coordinate closely with engineering, vendors, and quality to ensure equipment meets URS requirements, integrates seamlessly into broader systems, and complies with GMP, validation, and documentation standards
• Maintain accountability for on-time, on-budget, and in-spec project delivery
• Work inside PMO and help develop consistency in standardization, tools, and methods
• Open to travel including domestic and international
• Technical & Engineering Integration
• Interface directly with engineering teams (mechanical, electrical, process, controls) internally and client facing to ensure design intent aligns with project requirements
• Translate customer/user requirements into executable project scope and technical deliverables
• Identify and manage technical risks, trade-offs, and change controls

GMP & Regulatory Compliance

• Ensure all project activities align with GMP, FDA, and applicable regulatory standards
• Support validation efforts (IQ/OQ/PQ), documentation, and quality system compliance
• Coordinate with Quality Assurance to ensure proper documentation, traceability, and audit readiness

Customer & Stakeholder Management

• Serve as primary point of contact for customers throughout project lifecycle
• Lead project reviews, status updates, and milestone presentations
• Manage expectations and proactively resolve issues

Financial & Commercial Oversight

• Track project costs, margins, and financial performance
• Support change order management and scope adjustments
• Partner with sales and leadership on contract execution and risk mitigation

Required Qualifications

Education & Experience

• Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical, or related)
• 5–10+ years of project management experience in life sciences, biotech, pharma, or regulated environments
• Construction experience in a CGMP cleanroom environment is a plus.
• Demonstrated experience managing capital projects within GMP-regulated environments, biopharma or GC experience is a plus.

Technical & Domain Expertise

• Strong understanding of cleanroom systems, controlled environments, or similar engineered systems (HVAC, process systems, modular builds)
• Working knowledge of GMP, FDA regulations, and qualification processes (IQ/OQ/PQ)
• Experience with engineering documentation, design reviews, and change control processes

Project Management Capability

• Proven track record managing complex, multi-disciplinary projects
• Strong command of project management tools (Primavera, P6, MSP, etc)
• Familiarity with formal PM methodologies (PMP preferred but not required)
• Preferred Qualifications
• Experience with modular construction, mobile labs, or prefabricated systems
• Exposure to biosafety levels (BSL), containment systems, or advanced lab environments
• Experience with GMP-critical equipment systems such as isolators, containment systems, and aseptic processing equipment, including integration into facility and process environments
• PMP certification or equivalent
• Experience working with government contracts (DoD, BARDA, NIH) is a plus

Key Competencies