Director of Facilities Engineering & GMP Compliance

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

Benefits offered by this job

Defined career path with annual review

Diverse and inclusive culture

Tuition reimbursement program

Medical, dental, and vision benefits

8 paid holidays

Job summary

Catalent Pharma Solutions in Harmans, MD is seeking an Associate Director of Engineering, Facilities to provide strategic leadership for facilities engineering, maintenance and metrology, ensuring robust preventive maintenance, calibration and compliance to GMP and FDA guidelines.

The role leads a high‑performing team, manages capital projects, and partners with Quality and Regulatory to support clinical and commercial manufacturing at the Harmans site, with an onsite schedule and strong

Qualifications

• Bachelor’s degree in Science or Engineering with 10+ years of engineering experience.
• 7+ years of GMP or bio-pharma maintenance/engineering experience.
• Minimum 4 years of progressive leadership experience.
• Deep knowledge of FDA guidelines and 21 CFR Part 11, USP, ICH, ISPE GAMP.
• Experience representing Facilities in audits and inspections.

Responsibilities

• Lead, mentor, and develop facilities engineering teams.
• Define departmental strategies aligned with site and corporate goals.
• Promote ownership, technical excellence, and continuous improvement.
• Contribute to strategic planning, capital project prioritization, and site performance initiatives.
• Oversee resource planning, talent development, and succession planning.
• Champions safety, quality, and regulatory compliance.
• Lead projects from start to finish with engineers and contractors.
• Act as SME for Facility, Utility, and HVAC equipment.
• Review and approve SOPs; support validation lifecycle.

Skills

Leadership

Communication

Documentation

MS Office

Independent work

Education

Bachelor’s degree in Science or Engineering

Job description

Catalent Pharma Solutions in Harmans, MD is seeking an Associate Director of Engineering, Facilities to provide strategic leadership for facilities engineering, maintenance and metrology, ensuring robust preventive maintenance, calibration and compliance to GMP and FDA guidelines.

The role leads a high‑performing team, manages capital projects, and partners with Quality and Regulatory to support clinical and commercial manufacturing at the Harmans site, with an onsite schedule and strong