Reliability Engineering Manager

Catalent•Harmans, MD

5d•$145,000 - $165,000•Onsite

About The Position

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. We have an opportunity for a Reliability Engineering Manager to join our team and ensure the reliability and maintainability of new and modified systems and equipment supporting Maryland operations. This role sets reliability standards and evaluates processes, facilities, and utility equipment to improve performance through maintenance programs, spare parts strategies, and operating conditions. The Reliability Engineering Manager partners with production and maintenance teams to drive operational reliability and oversees continuous improvement of maintenance processes. All activities are performed in compliance with current Good Manufacturing Practices, company policies, and standard operating procedures.

Requirements

Bachelor of Science degree required; Engineering degrees preferred, especially Chemical or Mechanical Engineering.
5 years of related work experience in reliability engineering.
Proven abilities in mechanical and electrical design, repairs, and maintenance.
Experience using problem-solving and continuous improvement techniques.
Ability to communicate clearly in English, both verbally and in writing.
Experience with Root Cause Analysis, Failure Mode Effectiveness Analysis, Statistical Process Control, reliability modeling, Fault Tree Analysis, Weibull Analysis, and Six Sigma tools.
Strong technical writing skills to communicate technical ideas effectively.
Ability to work to targets and deadlines with strong planning and organizational skills.
Flexibility to support ongoing manufacturing operations in a dynamic environment.
Ability to lift and carry up to 50 pounds regularly.
Ability to stand, walk, bend, stoop, and climb ladders or step stools for extended periods.
Manual dexterity and visual acuity to operate and repair tools, equipment, and systems.
Capable of working in confined spaces, mechanical rooms, or at varying heights.
Tolerance for exposure to noise, vibration, varying temperatures, and industrial environments.
Ability to wear appropriate personal protective equipment including gloves, safety glasses, hearing protection, and respirators as required.
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.

Nice To Haves

Experience in GMP or Bio-Pharma maintenance and engineering environments.
Knowledge of biopharmaceutical equipment design, construction, operation, qualification, and maintenance, including bioreactors, chromatography systems, filtration systems, controlled temperature units, utility systems, and laboratory equipment.

Responsibilities

Lead the development, implementation, monitoring, and improvement of the site Equipment Reliability Program, including preventive and predictive maintenance, condition monitoring, and non-destructive testing.
Provide reliability engineering expertise and input to the Business Continuity Plan to identify and mitigate operational risks.
Direct engineering solutions for recurring equipment failures and performance issues, applying data-driven tools such as Statistical Process Control, reliability modeling, Fault Tree Analysis, Weibull Analysis, and Six Sigma principles.
Oversee Root Cause Analysis and Failure Modes and Effects Analysis to ensure effective corrective and preventive actions.
Collaborate with Manufacturing, Engineering, and MS&T to evaluate asset performance using metrics like Asset Utilization and Overall Equipment Effectiveness, driving continuous improvement.
Provide technical leadership and reliability engineering support to manufacturing and engineering teams.
Manage cost-benefit analysis for repair versus replace, repair versus redesign, and make versus buy decisions.
Champion equipment upgrades, modifications, and reliability improvement initiatives, ensuring compliance with change control processes.
Manage purchase requisitions and oversee operating and capital budgets.
Ensure compliance with Safety, Quality, and cGMP requirements, fostering a culture of operational excellence and continuous improvement.
Lead engineering solutions for maintenance, quality, safety, and failure investigations for manufacturing equipment and systems.