Director of Engineering, Facilities, and Validation

Catalent Pharma Solutions•Glen Burnie, MD

1d•$220,000 - $290,000•Onsite

About The Position

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.

Requirements

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 systems.
Understanding of financial concepts impacting capital investment and business EBITDA.
Strong negotiation and conflict resolution skills.
Ability to manage and prioritize multiple projects effectively.
Knowledge of FDA healthcare compliance rules and regulations.
Must be able to work in different areas of the building, including office spaces, technical spaces, manufacturing areas, and warehouse environments.

Nice To Haves

Experience in gene therapy preferred.
Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent‑sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.

Responsibilities

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.