Head of Facilities and Engineering

2 days ago


Gaithersburg, United States Joulé Full time

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

#LIMD1
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