We are seeking an experienced and forward-thinking
Director of Facilities, Engineering & Maintenance to lead all aspects of our US facility operations, engineering strategy, and infrastructure development across our GMP manufacturing and research environments. This role is critical to ensuring our US facilities operate safely, reliably, and in full compliance with regulatory standards. The ideal candidate brings deep technical expertise in biotech or pharmaceutical facility operations, strong leadership capabilities, and a passion for building high performance teams and systems.
FLSA Classification: Salaried, Exempt
Schedule: 8:00 AM - 5:00 PM; Monday to Friday; On-site
Reports to: Chief Operating Officer
Location: 13203 Murphy Road, Suite 100, Stafford, TX 77477
What You'll Do: As a
Director of Facilities, Engineering & Maintenance, you will play a key role in supporting our US facility operations:
- Develop and execute the long-term facility engineering & maintenance strategy to support company growth, GMP manufacturing capacity, and R&D operations.
- Accountable for scaling the facility infrastructure for commercial manufacturing, inspection readiness, uptime and cost-efficient operation.
- Lead capital planning, budgeting, and prioritization for facility upgrades, expansions, and construction.
- Serve as the primary engineering advisor to senior leadership, providing insights on infrastructure readiness, risk, and operational performance.
- Oversee the operation, maintenance, and lifecycle management of all critical building systems, including HVAC, clean rooms, utilities, automation, and process equipment.
- Ensure uninterrupted operation of GMP and laboratory facilities through robust preventive and predictive maintenance programs, and establishing an alarm escalation chain.
- Establish engineering standards, SOPs, and best practices to ensure consistent, compliant, and efficient facility operations.
- Ensure all facility systems meet regulatory requirements (FDA, EMA, ISO, cGMP, CLIA) and maintain audit readiness.
- Partner with Quality Assurance to manage deviations, CAPAs, change controls, and validation activities related to facility infrastructure.
- Partner with Computer System Validation to manage validation of new equipment.
- Oversee qualification and validation of utilities and equipment (e.g., HVAC, WFI, clean steam, compressed gases, BMS/EMS).
- Lead the planning, design, and execution of facility engineering projects, including cleanroom builds, utility upgrades, and equipment installations.
- Manage external engineering firms, contractors, and vendors to ensure projects are delivered on time, within budget, and to specification.
- Implement strong project governance, documentation, and risk management practices.
- Responsible for EHS-related compliance on site.
- Drive sustainability initiatives related to energy efficiency, waste reduction, and environmental impact.
- Oversee emergency response systems, business continuity planning, and facility risk assessments for the facilities, engineering & maintenance department.
- Build, mentor, and lead high performing multidisciplinary engineering team.
- Foster a culture of accountability, continuous improvement, and cross functional collaboration.
- Develop training programs to ensure staff competency in GMP, safety, and technical disciplines.
- Oversee vendor relationships for facility services, maintenance contracts, and engineering support.
- Negotiate service agreements and ensure vendor performance meets operational and compliance standards.
- Manage departmental budgets, cost controls, and resource allocation.
Required Experience and Education: - Bachelor's degree in Engineering (Mechanical, Electrical, Chemical, or related field).
- 10+ years of facilities, engineering & maintenance experience in biotech, pharmaceutical, or other regulated life science environments.
- 5+ years of leadership experience managing engineering or facility operations teams.
- Demonstrated experience in at least some of the following: leading GMP facility start-up or expansion projects, managing critical utilities and cleanrooms in regulated manufacturing, running maintenance/reliability programs, handling audits/inspections, and building teams in a fast-growth biotech environment.
- Strong knowledge of GMP regulations, cleanroom operations, and critical utilities.
- Proven experience leading capital projects and managing external contractors.
- Demonstrated ability to operate in fast-paced, high-growth environments.
- Must be authorized to work in the U.S.
Preferred Experience and Education: - Experience with facilities, engineering & maintenance in a commercial-stage cGMP environment
- Master's degree in engineering, Facilities Management, or related discipline.
- Experience in cell therapy, biologics manufacturing, or advanced therapy medicinal products (ATMPs).
- Certification in Project Management (PMP), Facilities Management (CFM), or similar.
- Experience with state-of-the-art BMS/EMS systems, ERP systems, MES systems, LIMS systems, automation platforms, digital maintenance systems and regulatory asset management systems.
Competencies - Interpersonal Communication
Work Environment: This is a sedentary position (at least 50% of time) in a typical office environment. There may be frequent interruptions with moderate noise levels and frequent use of printers, copiers, scanners, computers and other office equipment. Ability to sit, talk, walk, hear and communicate verbally and in writing is required. Occasional lifting of objects up to 25 lbs. is expected.
Travel required: up to 10% travel required, domestically and internationally.
Physical demands: - Communicating Verbally - expressing or exchanging ideas by means of the spoken word to impart oral information to others to convey detailed spoken instructions or other workers accurately, loudly or quickly.
- Hearing - the ability to hear, understand, and distinguish speech and/or other sounds one-on-one, group or conference, telephone, and other sounds.
- Keyboarding - entering data or text into a computer or other machine by means of a keyboard. Devices include a traditional keyboard, 10 key-pad, touch screens and others.
- Lifting - raising or lowering an object (up to 25 lbs) from one level to another (includes upward pulling). Carrying is to transport an object - usually by holding it in the hands or arms but may occur on the shoulder.
- Near Visual Acuity - clarity of vision at approximately 20 inches or less (working with small objects, reading small print, including the use of computers).
- Pushing - Exerting force upon an object so that the object moves away from the object.
- Pulling - Exerting force upon an object so that the object moves toward the force.
- Sitting - remaining in a sitting position for at least 50% of the time.
- Standing/Walking - remain on one's feet in an upright position at a workstation.
- Stooping - occasional bending the body downward and forward by bending the spine at the waist - requiring full use of the lower extremities and back muscles.
