Facilities Director

Key Responsibilities

• Provide leadership and oversight for GMP manufacturing suites, cleanrooms, QC laboratories, and site infrastructure.
• Ensure reliable operation of critical utilities, including HVAC, HEPA filtration, clean utilities, compressed gases, backup power, and environmental monitoring systems.
• Establish and maintain robust preventive maintenance, calibration, and asset lifecycle management programs.
• Identify, troubleshoot, and resolve infrastructure-related issues minimizing operational disruption.
• Improve systems and processes related to calibration, preventive maintenance, and work orders.
• Ensure facilities and utilities operate in full compliance with applicable cGMP and global regulatory expectations.
• Partner closely with Quality to manage deviations, change controls, CAPAs, and risk assessments related to facilities and utilities.
• Maintain facilities in a validated state and ensure readiness for inspections at all times.
• Lead facilities-related support during regulatory inspections and internal audits.
• Ensure appropriate documentation practices and adherence to cGMP policies and procedures.
• Lead capital planning and execution for facility expansions, upgrades, and infrastructure improvements.
• Oversee end-to-end project delivery, including design, construction, commissioning, qualification, and validation (CQV).
• Manage external partners including architects, engineers, contractors, commissioning and technical service providers.
• Ensure projects are delivered on schedule, within budget, and in compliance with GMP and operational requirements.
• Develop and manage operating and capital budgets aligned with strategic long-term priorities.
• Manage and optimize relationships with facilities vendors, contractors, engineering firms, and service providers.
• Identify and implement cost efficiencies while maintaining quality, safety, and regulatory compliance.
• Monitor operational performance using defined key performance indicators.
• Build and develop a high-performing facilities and maintenance organization.
• Establish clear roles, accountability, and performance expectations.
• Foster a culture of safety, compliance, accountability, and operational excellence.
• Mentor team members and support professional development.

Required Qualifications

• Bachelor’s degree in engineering, Facilities Management, or related technical field (advanced degree preferred).
• 8–12+ years of progressive facilities leadership experience in biotech, biopharma, or cell/gene therapy manufacturing.
• Strong hands-on knowledge of GMP cleanroom environments and regulated manufacturing infrastructure.
• Demonstrated experience supporting regulatory inspections and audits.
• Experience leading capital projects, renovations, or facility expansions.
• Strong knowledge of HVAC systems supporting cleanroom classifications and controlled environments.
• Proven ability to manage vendors and technical service providers.
• Excellent organizational, problem-solving, and communication skills.
• Ability to work on-site and wear appropriate personal protective equipment as required.

Preferred Experience

• Experience in cell therapy, gene therapy, or other advanced therapy medicinal products (ATMPs).
• Experience supporting clinical-stage manufacturing.
• Familiarity with single-use systems and aseptic processing environments.
• Experience scaling from clinical to commercial.