Director of Engineering, Facilities, and Validation

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

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.

The Candidate

• ✓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.
• ✓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.
• ✓Must be able to work in different areas of the building, including office spaces, technical spaces, manufacturing areas, and warehouse environments.