Senior GMP Project Manager – Life Sciences

Evolving Solution Services; Ormond Beach (FL); On-site; USD 90,000 - 130,000; Full time

Job summary

Germfree is seeking a technically grounded Senior Project Manager with a strong engineering foundation and experience in regulated life sciences environments. This role leads complex projects from design through validation and delivery of controlled environment solutions, ensuring GMP, FDA, and ISO standards are met.

The ideal candidate will coordinate engineering, manufacturing, quality, and supply chain teams, manage budgets and schedules, and travel as needed.

Qualifications

• 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.
• Strong understanding of GMP, FDA regulations, and qualification processes (IQ/OQ/PQ).
• Experience with engineering documentation, design reviews, and change control processes.

Responsibilities

• 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.

Skills

Project management

Regulatory compliance

Cross-functional coordination

Technical credibility

Communication

Education

Bachelor's degree in Engineering

Tools

Primavera

P6

MSP

Job description

Germfree is seeking a technically grounded Senior Project Manager with a strong engineering foundation and experience in regulated life sciences environments. This role leads complex projects from design through validation and delivery of controlled environment solutions, ensuring GMP, FDA, and ISO standards are met.

The ideal candidate will coordinate engineering, manufacturing, quality, and supply chain teams, manage budgets and schedules, and travel as needed.