Associate Director of Engineering, Facilities

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

Associate Director of Engineering, Facilities

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).

The Candidate

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.

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life‑saving and life‑enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

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

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