Director of Engineering, Facilities, and Validation

About Site

Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus, featuring two manufacturing facilities, is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location. The campus is close to Washington, DC’s I-270 Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq.

ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse. The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing. Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines.

We have an opportunity for a Director of Engineering, Facilities, and Validation to join our team. This role leads a multi-disciplinary group responsible for maintaining and advancing our state-of-the-art gene therapy development and manufacturing facilities. The Director provides strategic and operational leadership across Facilities Maintenance, Metrology, Clean Utilities, Project Engineering, Automation, and Equipment & Facility Validation. The position ensures reliability, compliance, and continuous improvement for all site assets while managing the site’s Capital Expenditure program.

As a key member of the Site Leadership Team, the Director collaborates cross‑functionally to align engineering strategy with business goals and support 24/7 operations across multiple facilities.

Location:

Harmans, MD - BWI 100% Onsite

• Oversee management of buildings, equipment, and grounds, maintaining all files, drawings, and records required for GMP operations.
• Attract, recruit, develop, and retain talent to achieve business goals.
• Manage capital and non‑capital projects to improve capacity, quality, efficiency, utilization, and environmental health and safety.
• Lead long‑term capital planning, forecasting, and departmental budgeting.
• Implement lean transformation initiatives focused on waste reduction.
• Develop maintenance optimization initiatives to improve reliability and reduce costs.
• Drive projects to maximize output, minimize cost, and enhance efficiency and EHS performance.
• Collaborate with site, business unit, corporate, and supplier personnel to maintain effective communication and relationships.
• Ensure compliance with cGMP regulations and environmental requirements at all levels.
• Maintain compliance with planned maintenance and calibration schedules.
• Ensure the Computerized Maintenance Management System remains current.
• Work with Manufacturing and Quality teams to ensure equipment and facilities are available and reliable.
• Evaluate best practices across the network and external resources.
• Own asset readiness as part of the new product introduction process.
• Serve as a member of the Site Leadership Team and demonstrate ownership of business unit goals and objectives.
• Act as the primary resource for emerging compliance trends and partner with stakeholders to address them.

• Experience in the biotech industry required.
• Bachelor of Science in Engineering or Science discipline.
• Extensive (10+ years) industrial maintenance experience involving mechanical, electrical, and electronics in a cGMP regulated environment.
• Strong experience with capital expenditure and project‑related work.
• Working knowledge of automation control, alert, and data collection/retention systems.
• Working knowledge of HVAC and clean utility…