Associate Director of Engineering, Facilities

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

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

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).

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.

Equal Opportunity Employer

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

Accommodation for Applicants with Disabilities

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.

About Catalent

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life‑enhancing and life‑saving treatments for patients annually.