Facilities Engineering Director, Biotech Manufacturing

Catalent Pharma Solutions; Glen Burnie (MD); On-site; USD 170,000 - 210,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

Tuition reimbursement

Paid time off

8 paid holidays

Job summary

Catalent Pharma Solutions seeks an Associate Director of Engineering, Facilities in Harmans, MD. This leadership role oversees Facilities Engineering, Maintenance, and Metrology with a focus on preventive maintenance, calibration, and compliant operations for GMP manufacturing.

The role requires leadership experience, deep FDA/gMP knowledge, and the ability to drive safety, quality, and continuous improvement across multiple programs. Onsite work with competitive compensation and benefits awaits.

Qualifications

• Bachelor’s degree in Science or Engineering plus 10+ years engineering experience.
• Minimum 7 years GMP/Bio-Pharma maintenance/engineering experience.
• Minimum 4 years progressive leadership experience with people development.
• In-depth knowledge of FDA guidelines and global cGMPs (21 CFR Part 11, USP, ICH, ISPE GAMP).

Responsibilities

• Lead facilities engineering, maintenance, and metrology teams.
• Define strategies aligned with site and corporate goals.
• Oversee capital projects, risk management, and safety/compliance initiatives.
• Lead projects from start to finish, coordinating engineers and contractors.
• Review and approve qualification protocols (IQ/OQ/PQ) and change controls.

Skills

Leadership

Regulatory compliance

Facilities engineering

Project management

Technical writing

MS Office

Education

Bachelor’s degree in Science or Engineering

Tools

CMMS

Job description

Catalent Pharma Solutions seeks an Associate Director of Engineering, Facilities in Harmans, MD. This leadership role oversees Facilities Engineering, Maintenance, and Metrology with a focus on preventive maintenance, calibration, and compliant operations for GMP manufacturing.

The role requires leadership experience, deep FDA/gMP knowledge, and the ability to drive safety, quality, and continuous improvement across multiple programs. Onsite work with competitive compensation and benefits awaits.