Director of Engineering & Facilities, Gene Therapy Manufacturing

Catalent Pharma Solutions; Maryland; On-site; USD 220,000 - 290,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

Tuition reimbursement

Paid time off

8 paid holidays

Career growth opportunities

Job summary

Catalent, a leading gene therapy contract development and manufacturing organization, seeks a Director of Engineering, Facilities, and Validation to lead multi-disciplinary teams across Maintenance, Metrology, Clean Utilities, and Validation. You will drive reliability, compliance, and capital expenditure programs while enabling 24/7 operations at the Harmans, MD site.

Location: Harmans, MD; Onsite. The role requires strategic and operational leadership with a focus on continuous improvement and

Qualifications

• Experience in biotech or a regulated environment is required.
• Bachelor of Science in Engineering or Science discipline.
• 10+ years of industrial maintenance in a cGMP setting.
• Strong experience with capital expenditure & project work.
• Knowledge of automation control, data collection, and retention systems.
• Understanding of HVAC and clean utility systems.
• Familiarity with FDA healthcare compliance rules.
• Leadership experience within Catalent preferred or equivalent leadership programs.

Responsibilities

• Oversee management of buildings, equipment, and grounds with GMP recordkeeping.
• Attract, recruit, develop, and retain talent to meet business goals.
• Manage capital and non-capital projects to improve capacity, quality, and efficiency.
• Lead long-term capital planning, forecasting, and budgeting.
• Implement lean initiatives to reduce waste.
• Develop maintenance optimization to improve reliability and reduce costs.
• Drive projects to maximize output and minimize cost and improve EHS.
• Collaborate with site, business unit, corporate, and supplier personnel.
• Ensure compliance with cGMP and environmental requirements.
• Maintain planned maintenance and calibration schedules.
• Keep the Computerized Maintenance Management System current.
• Ensure equipment and facilities availability with Manufacturing and Quality teams.
• Evaluate best practices across network and external resources.
• Own asset readiness for new product introduction.
• Serve on Site Leadership Team and align with business goals.
• Address emerging compliance trends with stakeholders.

Skills

Leadership

Project management

Budget planning

Negotiation

Prioritization

Cross-functional collaboration

Education

BS in Engineering or Science

Tools

Automation control systems

HVAC & clean utilities

cGMP regulatory know-how

Job description

Catalent, a leading gene therapy contract development and manufacturing organization, seeks a Director of Engineering, Facilities, and Validation to lead multi-disciplinary teams across Maintenance, Metrology, Clean Utilities, and Validation. You will drive reliability, compliance, and capital expenditure programs while enabling 24/7 operations at the Harmans, MD site.

Location: Harmans, MD; Onsite. The role requires strategic and operational leadership with a focus on continuous improvement and