Head of Facilities and Engineering

Title: Director of Facilities and Engineering
Location: Onsite at Gaithersburg, Maryland 20878
Schedule: M-F 8:00 AM-5:00 PM
Pay: Competitive, plus equity and other benefits
Type: Direct/Permanent
Start date: Immediate

Overview: Great opportunity to be part of a dedicated team serving the rapidly expanding gene therapy market who aims to become a leading supplier of high-quality Lentiviral vectors for research and clinical use. You will leverage your expertise in Facility and cleanroom operations to ensure maximum up-time and compliant manufacture of viral vectors intended for human clinical use. This position requires a broad understanding of the equipment, utilities and quality systems needed to maintain cGMP compliant operations.

Responsibilities:

• Oversee day to day operations of approximately 25,000 sq ft of combined office, laboratory and GMP cleanroom space.
• Emphasis on maintaining all systems required to ensure compliance and operation of GMP manufacturing operations.
• Coordinate with Landlord for general facilities maintenance and upkeep.
• Manage in-house and contract activities to achieve goals.
• Manage all aspects of equipment and systems lifecycle
• Design review and criticality assessment
• Equipment installation and Operation Qualification (IOQ)
• Preventive Maintenance & Calibrations (metrology program)
• Create and maintain equipment master file
• Ensure documentation detailing service, maintenance, etc.
• Ensure operation and maintenance of HVAC system supporting cGMP cleanrooms
• Requires good understanding of mechanical and control systems for cleanroom HVAC operation in order to manage contractors for support
• Work effectively with all stakeholders to assess and prioritize needs and coordinate internal and contract activities to ensure completion of work
• Understand and apply GMP principals and regulatory guidance that governs best practices for Facilities, Equipment and Utilities operations.

Requirements:
Basic Qualifications

• Education: Bachelor's degree in relevant discipline preferred but professional experience in appropriate role may substitute.
• Experience: Minimum of 10 years demonstrated leadership and accomplishment in a Facility and Engineering role within the Biotech/Pharma sector requiring cGMP compliance.
• Skills:
• Strong understanding of cGMP's, regulatory requirements, and quality systems.
• Excellent troubleshooting, problem-solving skills and attention to detail.
• Proven ability to work effectively in a team environment and mentor junior staff.
• Strong written and verbal communication skills.
• Proficiency in Microsoft 365 (Word, Excel, PowerPoint, Teams, SharePoint, OneDrive).

Preferred Qualifications

• Thorough understanding of Equipment lifecycle
• Working knowledge of typical bioprocess equipment and systems
• Familiar with typical QC analytical equipment (PM & cal requirements)
• Knowledgeable regarding cleanroom air classifications and QC environmental monitoring program
• Proficient with Building monitoring systems operations and alarm response
• Proficient with electronic equipment management systems
• Thorough understanding of quality documentation requirements
• Good familiarity with computerized systems, data networks, data integrity

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