Director of Engineering, Facilities, and Validation
Position Summary:
- 100% on-site in Harmans, MD
Catalent is a leading global CDMO partnering with pharma and biotech innovators to accelerate development and delivery of life-changing therapies. Our FDA-licensed, state-of-the-art CGMP gene therapy campus in Harmans, MD—just minutes from BWI Airport—features EMA and FDA-approved manufacturing suites, fill/finish capabilities, labs, and warehousing to support Phase 3 through commercial production of advanced therapies, including AAV and other viral vector-based products.
Catalent’s Gene Therapy division is seeking a Director of Engineering, Facilities & Validation to lead a multi-disciplinary team responsible for maintaining and advancing our state-of-the-art gene therapy development and manufacturing facilities. This role provides strategic and operational leadership across Facilities Maintenance, Metrology, Clean Utilities, Project Engineering, Automation, and Equipment & Facility Validation. The Director ensures reliability, compliance, and continuous improvement for all site assets while owning the site’s Capital Expenditure (CapEx) program. As a key member of the Site Leadership Team reporting the VP/GM for Maryland, the Director will collaborate cross-functionally to align engineering strategy with business goals and support 24/7 operations across multiple facilities.
The Role:
- Assumes overall accountability for the management of building, equipment, and grounds. Maintain relevant files, drawings, and records required for a GMP operation.
- Attracts, recruits, develops and retains the talent to deliver business goals.
- Manage capital and non-capital projects to improve capacity, quality, efficiency, utilization and EHS.
- Responsible for long-term capital plan and forecasting as well as departmental budget.
- Execute a lean transformation environment with a focus on waste reduction
- Develop repair & maintenance spend optimization initiatives to improve overall reliability of the facility and minimize cost expenditures
- Consult and cooperate with site/business unit/corporate/supplier personnel as authorized and required, maintaining effective communications and working relations.
- Ensure a relevant knowledge base in place to best manage programs with respect to governing cGMP regulations, requirements of city, state and federal permitting and environmental agencies as it relates to the business.
- Collaborate with Manufacturing and Quality teams to ensure equipment and facility remains available for use and does not impact the ability to deliver projects and products.
- Other duties as assigned.
The Candidate:
- Bachelor of Science in Engineering or Science discipline required.
- 10+ years’ experience prior industrial maintenance experience involving mechanical, electrical and electronics in a cGMP regulated environment required.
- Must have extensive experience with capital expenditure and project related work.
- Working knowledge of automation control, alert and data collection/retention systems.
- Working knowledge of HVAC and clean utility systems.
- Understands financial concepts that impact capital investment and business EBITDA.
- Must possess good negotiation and conflict resolution skills
- Must be able to manage and prioritize work on multiple fronts.
- Knowledge of FDA Healthcare compliance rules and regulations
- 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 Massachusetts is $250k-290k plus an annual bonus target. 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:
- Comprehensive Benefit Package (Health, Dental, Vision, & Life Insurance).
- Group Retirement Savings- Registered Pension Plan (RPP) with employer contributions.
- Paid Time Off Programs including Vacation, banked time, and personal time.
- Employee Reward and Recognition Programs.
- Opportunities for professional and personal development.
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.
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 [email protected]. 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.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to [email protected] for us to investigate with local authorities.
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