Project Manager, GMP Facilities & Validation

Forge Biologics - Columbus, OH

Full-time - Mid Level

Columbus, OH

Professional, Scientific, and Technical Services

About the position

The Facilities & Validation Project Manager at Forge Biologics plays a critical role in managing projects related to the growth and development of GMP facilities and systems. This role requires strong leadership, organizational, and communication skills to ensure projects are completed on time, within scope, and on budget. The Project Manager will work closely with cross-functional teams, stakeholders, and external partners, primarily collaborating with Forge's Facilities & Engineering, Manufacturing, Supply Operations, and Quality Validation Teams. The ideal candidate will have experience managing projects in GMP environment with a focus on equipment validation, facility release, and quality change controls.

Responsibilities

• Develop and maintain comprehensive project plans, including scope, timelines, resources, and budgets.
• Lead project teams to meet quality and compliance standards, ensuring timely execution.
• Build and maintain strong relationships with internal and external stakeholders, ensuring clear communication, alignment on project goals, and effective issue resolution.
• Manage project resources, including personnel, budget, and technology, to support project success.
• Ensure adherence to quality standards, best practices, and compliance.
• Maintain project documentation, including status reports, project charters, and other relevant documents, and provide regular updates to senior leadership and stakeholders.
• Implement change management strategies and communicate project changes as needed.
• Coordinate with engineering, facilities, and quality teams to ensure the timely installation, commissioning, and qualification of equipment and systems.
• Oversee the validation process for critical systems, including HVAC, water systems, and production equipment to ensure all systems are compliant with GMP regulations and company SOP's.
• Work closely with internal stakeholders, including Quality Assurance, Manufacturing, and Engineering teams, to ensure seamless project execution and compliance with GMP standards.
• Identify potential risks associated with GMP facilities and systems projects and develop mitigation strategies to address these risks proactively.
• Maintain detailed project documentation, including validation protocols, change controls, and status reports, ensuring all documentation meets regulatory and company requirements.
• Drive continuous improvement initiatives related to GMP facilities and systems, identifying opportunities for process optimization.
• Serve as the primary point of contact for all GMP facility and systems projects, providing regular updates to senior management and other stakeholders.

Requirements

• 5+ years of project management experience within a GMP-regulated environment, ideally in CDMO or pharmaceutical manufacturing.
• Strong knowledge of GMP regulations, particularly in facility and system validation.
• Experience partnering with quality systems teams/function.
• Proven experience managing complex, cross-functional projects.
• Excellent communication, organizational, and problem-solving skills.
• Ability to work independently and manage multiple priorities in a fast-paced environment.

Nice-to-haves

• Knowledge of regulatory requirements for system validation (e.g., FDA, EMA).
• Familiarity with Lean Six Sigma or other process improvement methodologies.
• Project Management Certifications (e.g., PMP).

Benefits

• Health, Dental, and Vision insurance that starts on your first day at Forge, with 90% of premiums covered for team members as well as dependents
• Flexible PTO (plus 14 paid company holidays)
• Annual bonus for all full-time employees
• 401(K) company match
• Fully-stocked kitchen with free food/drinks
• 12 weeks of paid parental leave - additional discount programs include childcare support & dependent care
• Employee Assistance Program
• Wellness benefits (financial planning services, mental health counseling, employer paid disability)
• Professional & Personal development resources - LinkedIn Learning, a dedicate training staff in-house, mentoring opportunities & access to leadership development coaches