Senior Process Engineer

Catalent • Harmans, MD

9d • Onsite

About The Position

The Senior Process Engineer supports the introduction of new biopharmaceutical products at development and manufacturing sites. The role focuses on liquid formulations produced using single-use systems in a cleanroom environment, including onboarding new process equipment, coordinating commissioning and qualification, and maintaining validated equipment status. This is a full-time, hands-on engineering role supporting a growing CDMO at Catalent’s Harmans, Maryland campus. The position is 100% onsite, Monday through Friday, 8 a.m. to 5 p.m.

The Harmans/BWI campus includes an FDA- and EMA-approved facility with approximately 200,000 square feet, 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse, as well as a second facility under development with approximately 145,000 square feet planned to house eight CGMP manufacturing suites and cold storage warehousing. The facilities support Phase 3 through commercial manufacturing of advanced therapeutic products, including AAV and other viral vector-based therapies and vaccines.

Requirements

• Bachelor’s degree in Engineering; Chemical or Mechanical Engineering is preferred. An equivalent combination of education, certifications, and relevant experience may be considered.
• 5–10 years of engineering or maintenance experience in a GMP-regulated biopharmaceutical or biotechnology manufacturing environment.
• Experience supporting bioprocess equipment, manufacturing operations, and facility systems.
• Experience with aseptic processing and fill/finish operations.
• Experience working in cGMP and regulated pharmaceutical environments.
• Ability to navigate site mechanical spaces, including stairs, ladders, and low overhead areas, and occasionally work in tight or awkward spaces such as behind equipment or in cleanroom utility chases.
• Ability to visually inspect equipment, read instruments, and review documentation clearly and accurately; corrected vision is acceptable.
• Ability to sit at a desk or computer for periods of time to prepare documentation, reports, and data analyses.
• Ability to occasionally lift and carry up to 40 pounds.
• Manual dexterity sufficient to operate tools, instruments, laptops, and measurement equipment.
• Ability to use PPE, including lab coats, gloves, safety goggles, and respiratory protection when required.

Nice To Haves

• Biopharmaceutical manufacturing experience is strongly preferred.
• CDMO experience, including experience with companies such as Catalent, Lonza, Thermo Fisher, Fujifilm Diosynth, AGC Biologics, Resilience, or WuXi.
• Experience in sterile injectable or aseptic manufacturing environments.
• Experience in biologics, cell culture, fermentation, and fill/finish operations.
• Experience in medical device, vaccine, or biotechnology manufacturing.
• Experience in adjacent regulated industries with a strong process equipment background may be considered.

Responsibilities

• Provide hands-on support as a bioprocess equipment subject matter expert and manufacturing support engineer.
• Support manufacturing floor operations by troubleshooting bioreactors, fermenters, chromatography skids, centrifuges, fillers, isolators, incubators, and utility systems.
• Collaborate with operators, mechanics, MS&T, and Quality to minimize downtime and resolve equipment issues.
• Execute preventive maintenance programs and close maintenance work orders in the CMMS system.
• Coordinate repairs with vendors and maintenance technicians, manage spare parts, and drive reliability improvements.
• Lead installation of new equipment and support commissioning and qualification activities, including IQ/OQ.
• Contribute to facility expansions and technology transfers, collaborating with Validation and Automation teams on SCADA integration.
• Prepare and review GMP documentation, including change controls, deviations, CAPAs, SOP revisions, and engineering reports.
• Conduct root cause investigations and risk assessments using tools such as FMEA, Fishbone, and 5-Why.
• Train operators, mechanics, and engineers, and support regulatory inspections as the equipment subject matter expert.
• Manage contractors and vendors and present engineering updates to leadership and project teams.

Benefits

• Competitive paid time off and 8 paid holidays.
• Medical, dental, and vision benefits effective on the first day of employment.
• Tuition reimbursement.
• Potential bonus.
• Defined career path and annual performance review and feedback process.
• Potential for career growth on an expanding team.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior