Director 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: Our client who is start-up CDMO that offers best-in-class Lentiviral vector platform is seeking an experienced Director of Facilities and Engineering. This role requires this Director to oversee all aspects of facility operations, maintenance, and engineering for a Contract Development and Manufacturing Organization (CDMO) as well as the day-to-day operations, including building maintenance, HVAC, utilities, cleanroom environments, and overall site infrastructure.

Responsibilities:

1. Oversee all aspects of facility operations, maintenance, and engineering for a Contract Development and Manufacturing Organization (CDMO) specializing in the production of lentiviral vectors.
2. Responsible for ensuring the facilities and engineering teams maintain a highly compliant, efficient, and safe environment, supporting manufacturing, research, and development activities
3. Oversee 3rd party contractors supporting facility maintenance and infrastructure
4. Oversee the day-to-day operations, including building maintenance, HVAC, utilities, cleanroom environments, and overall site infrastructure.

Requirements:

• Bachelor's or Master's degree in Engineering (Mechanical, Electrical, Chemical, or a related field) preferred.
• 10+ years of experience in facilities management and engineering, with at least 5 years in a leadership role within a biopharmaceutical, CDMO, or gene therapy manufacturing environment.
• Proven expertise in designing, building, and maintaining CGMP-compliant manufacturing facilities, especially those involved in viral vector production.
• Experience with the scale-up and technical transfer of biologic or gene therapy processes.
• Strong knowledge of regulatory compliance (FDA, EMA, OSHA) and facility safety standards.
• Deep understanding of facility utilities, cleanroom environments, and biologic containment systems.
• Proficiency in project management methodologies and tools.
• Familiarity with automation, process control, and HVAC systems tailored to biologics manufacturing.
• Proven leadership abilities with a strong track record in team management and cross-functional collaboration.
• Excellent communication skills for interacting with internal stakeholders, regulatory bodies, and external vendors.

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