Director of Engineering, Facilities & Validation (Onsite)

Catalent Pharma Solutions; Harmans (MD); On-site; USD 220,000 - 290,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

Tuition reimbursement

8 paid holidays

Paid time off

Job summary

Catalent Pharma Solutions in Harmans, MD seeks a Director of Engineering, Facilities, and Validation to lead a multi-disciplinary team maintaining and advancing our gene therapy development and manufacturing facilities. You will drive capital projects, automation, and validation programs to ensure reliability and compliance across 24/7 operations.

The role requires deep cGMP knowledge, extensive maintenance leadership, and collaboration with multiple stakeholders to align engineering strategy

Qualifications

• Experience in biotech industry.
• Bachelor of Science in Engineering or Science discipline.
• 10+ years industrial maintenance in a cGMP 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 EBITDA.
• Leadership experience (Catalent programs may count).
• Ability to work in different areas of a building.

Responsibilities

• Oversee management of buildings, equipment, and grounds, maintaining all GMP-relevant files and records.
• 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 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 EHS performance.
• Collaborate with site, business unit, corporate, and supplier personnel to maintain communication and relationships.
• Ensure compliance with cGMP and environmental requirements; maintain maintenance/calibration schedules.

Skills

Leadership

Project management

Financial acumen

Negotiation

Communication

Education

Bachelor of Science in Engineering or Science discipline

Tools

Automation control systems

Job description

Catalent Pharma Solutions in Harmans, MD seeks a Director of Engineering, Facilities, and Validation to lead a multi-disciplinary team maintaining and advancing our gene therapy development and manufacturing facilities. You will drive capital projects, automation, and validation programs to ensure reliability and compliance across 24/7 operations.

The role requires deep cGMP knowledge, extensive maintenance leadership, and collaboration with multiple stakeholders to align engineering strategy