Director of Engineering, Facilities, and Validation

Catalent

2d•Onsite

About The Position

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.

Requirements

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

Nice To Haves

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

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.

Benefits

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.

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