Director of Engineering, Facilities, and Validation

Catalent•Harmans, MD

13d•$220,000 - $290,000•Onsite

About The Position

The Director of Engineering, Facilities, and Validation leads a multidisciplinary group responsible for maintaining and advancing Catalent’s gene therapy development and manufacturing facilities in Harmans, Maryland. The role provides strategic and operational leadership across Facilities Maintenance, Metrology, Clean Utilities, Project Engineering, Automation, and Equipment and Facility Validation. It ensures site asset reliability, regulatory compliance, continuous improvement, and management of the site capital expenditure program. As a member of the Site Leadership Team, the Director collaborates across functions to align engineering strategy with business goals and support 24/7 operations across multiple facilities. The position is 100% onsite. The Harmans/BWI campus includes an approximately 200,000-square-foot FDA- and EMA-approved facility with 10 CGMP manufacturing suites, fill/finish, central services, testing laboratories, and a warehouse. A second facility, approximately 145,000 square feet and under development, is planned to include eight CGMP manufacturing suites and cold storage warehousing. The facilities support Phase 3 through commercial manufacturing of advanced therapeutic products, including AAV and other viral vector-based therapies and vaccines.

Requirements

Experience in the biotech industry.
Bachelor of Science in an engineering or science discipline.
At least 10 years of 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 and retention systems.
Working knowledge of HVAC and clean utility systems.
Understanding of financial concepts affecting 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.
Ability 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 is preferred.
Demonstrable leadership experience at Catalent, including 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 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.
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.