Associate Director of Engineering, Facilities

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

About Site

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.

About Site

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.

Position Summary

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.

Shift: Monday - Friday 8am-5pm

Location: Harmans, MD - BWI

100% Onsite

The Role

• 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).

Minimum 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.

Pay

The anticipated salary range for this position in MD is $170,000 – $210,000 Plus Bonus. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.

Why You Should Join Catalent

• Defined career path with annual performance reviews and feedback.
• Diverse and inclusive culture.
• Opportunities for career growth within an organization dedicated to improving lives.
• Competitive paid time off plus 8 paid holidays.
• Community engagement and green initiatives.
• Medical, dental, and vision benefits effective from day one.
• Tuition reimbursement program.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [e-mail]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Catalent is an Equal Opportunity Employer, including disability and veterans.

California Job Seekers can find our California Job Applicant Notice HERE.