Head of Facilities and Engineering

Title : Director of Facilities and Engineering

Candidates should take the time to read all the elements of this job advert carefully Please make your application promptly.

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 :

• 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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