Associate Director of Engineering, Facilities

Catalent•Harmans, MD

8d•$170,000 - $210,000•Onsite

About The Position

Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus, featuring two manufacturing facilities is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location. The campus is close to Washington, DC’s I-270 Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse. The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing. Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines. We have an opportunity for an Associate Director of Engineering, Facilities to join our team. This role provides strategic leadership for Facilities Engineering, Maintenance, and Metrology departments. You will ensure robust preventive maintenance, calibration, and engineering practices to support manufacturing and process development. The position oversees equipment readiness for clinical campaigns and commercial manufacturing, aligning with quality standards and regulatory requirements. You will foster a culture of accountability, innovation, and continuous improvement while leading a high-performing team.

Requirements

Bachelor’s degree in Science or Engineering field with 10+ years of engineering experience.
At least 7 years of related work experience in GMP or Bio-Pharma maintenance/engineering.
Minimum 4 years of progressive leadership experience, including performance management and people development.
In-depth knowledge of FDA guidelines and global cGMPs relevant to 21 CFR Part 11, USP, ICH, and ISPE GAMP guidelines.
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 setting with minimal supervision.
Strong written and verbal communication skills, including technical writing and clear documentation of complex concepts.
Detail-oriented with the ability to manage multiple priorities, meet deadlines, and effectively utilize MS Office and laboratory-related software.
Physically capable of working in industrial environments, including lifting up to 50 lbs., standing/walking for extended periods, operating tools and equipment, working at heights or in confined spaces, and wearing required PPE.
Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent‑sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of 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, technical excellence, and continuous improvement across teams.
Contribute to strategic planning, capital project prioritization, and site performance initiatives.
Oversee resource planning, talent development, and succession planning.
Champion safety, quality, and compliance initiatives while maintaining employee engagement.
Lead projects from start to finish, including documentation, scheduling, and oversight of engineers and contractors.
Act as subject matter expert on Facility, Utility, and HVAC equipment across all buildings.
Troubleshoot and repair bioprocess and facilities equipment, including water generation systems, pure gas systems, boilers, chillers, and HVAC units.
Work within Computerized Maintenance Management Systems (CMMS) for maintenance work orders.
Manage Quality Systems for change control, document revisions, and failure investigations.
Maintain engineering drawings and equipment history files.
Review and approve qualification protocols such as IQ/OQ/PQ.
Support validation lifecycle and compliance with regulatory guidelines.
Perform root cause analysis and support corrective and preventive actions.
Support risk management programs using tools like FMEA and FTA.
Serve as engineering subject matter expert for expansion projects, including cleanroom construction and utility qualification.
Review and approve Standard Operating Procedures (SOPs).