Director of Engineering, Facilities, and Validation

Position Summary

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.

The Role

• 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.

The Candidate

Minimum 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.
• 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.

Preferred Skills & Background

• Experience in gene therapy preferred.