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System One Director of Facilities and Engineering in Gaithersburg, Maryland

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:

  • Oversee all aspects of facility operations, maintenance, and engineering for a Contract Development and Manufacturing Organization (CDMO) specializing in the production of lentiviral vectors.

  • Responsible for ensuring the facilities and engineering teams maintain a highly compliant, efficient, and safe environment, supporting manufacturing, research, and development activities

  • Oversee 3rd party contractors supporting facility maintenance and infrastructure

  • 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.

    #LIMD1

    #M3

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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