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
#M3  

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions 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 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.