Statistical Process Control Engineer Jobs in Washington, DC

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.

Shift: Monday - Friday, 8am - 5:00pm
Location: Harmans, MD - BWI
100% Onsite

• 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.

• 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 Catalentsponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.

• 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.

The anticipated salary range for this position in MD is $145,000 - $165,000 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.

• 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.

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 DisabilityAccommodations@catalent.com. 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.

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