Senior Director, Facilities Engineering – GMP Biopharma

Catalent; Harmans (MD); On-site; USD 170,000 - 210,000; Full time

Benefits offered by this job

Paid time off

Benefits from day one

Job summary

Catalent seeks an Associate Director of Engineering, Facilities in Harmans, MD, to lead Facilities Engineering, Maintenance, and Metrology. You will drive preventive maintenance, calibration, and engineering practices to support clinical and commercial manufacturing, ensuring compliance with quality standards and regulatory guidelines.

This role requires strategic leadership and a track record of building high-performing teams.

Qualifications

• 10+ years of engineering experience in GMP/Bio-Pharma maintenance/engineering
• 7+ years of related work experience in GMP or Bio-Pharma maintenance/engineering
• 4+ years of progressive leadership experience
• In-depth knowledge of FDA guidelines and global cGMPs (21 CFR Part 11, USP, ICH, ISPE GAMP)
• Experience with compliance regulations for Quality, Regulatory Compliance, and Environmental Health and Safety
• Experience representing Facilities in audits and inspections
• Ability to work independently and in a team with minimal supervision
• Strong written and verbal communication skills and technical writing
• Physically capable of working in industrial environments (lifting up to 50 lbs., PPE, etc.)
• Catalent leadership programs experience may substitute external experience

Responsibilities

• Lead, mentor, and develop high-performing teams in facilities engineering, technical trades, and metrology
• Define departmental strategies and objectives aligned with site and corporate goals
• Promote ownership and continuous improvement across teams
• Oversee capital project prioritization and site performance initiatives
• Manage resource planning and succession planning
• Champion safety, quality, and compliance while maintaining engagement
• Lead projects from start to finish including documentation and scheduling
• Act as SME on Facility, Utility, and HVAC equipment across buildings
• Review and approve qualification protocols IQ/OQ/PQ and SOPs
• Support validation lifecycle and regulatory guidelines compliance
• Perform root cause analysis and support CAPA
• Support risk management with FMEA/FTA
• Serve as SME for expansion projects including cleanrooms and utility qualification

Skills

Leadership

Facilities Engineering

Maintenance & Metrology

Regulatory Knowledge

Technical Writing

Education

Bachelor’s degree in Science or Engineering

Tools

MS Office

Job description

Catalent seeks an Associate Director of Engineering, Facilities in Harmans, MD, to lead Facilities Engineering, Maintenance, and Metrology. You will drive preventive maintenance, calibration, and engineering practices to support clinical and commercial manufacturing, ensuring compliance with quality standards and regulatory guidelines.

This role requires strategic leadership and a track record of building high-performing teams.