Senior Automation Engineer

Catalent•Harmans, MD

10d•Onsite

About The Position

Catalent is hiring a Senior Automation Engineer to support automated and computerized systems used in manufacturing and Facilities and Utility operations at its Harmans/BWI campus. The role serves as system owner and automation subject-matter expert, leads complex troubleshooting and automation workstreams for major changes and capital projects, and mentors less-experienced engineers. The position reports to the Senior Manager, Automation Engineering. It is 100% onsite in Harmans, Maryland, Monday through Friday, 8 a.m. to 5 p.m., with after-hours escalation support for critical system failures. The campus supports Phase 3 through commercial manufacturing of advanced therapeutic products, including AAV and other viral vector-based therapies and vaccines. Its FDA-licensed, state-of-the-art CGMP facilities include manufacturing suites, fill/finish, central services, testing labs, warehouse space, and a facility under development that will include additional manufacturing suites and cold storage warehousing. The successful candidate will own assigned automation systems, monitor their performance, reliability, and data integrity, and identify improvements to uptime, maintainability, cybersecurity, and system effectiveness. The role requires coordination with vendors and integrators, cross-functional teams, and Quality, Validation, MS&T, Operations, Facilities, and Engineering. The engineer will help ensure systems operate reliably and comply with cGMP, GAMP, and data integrity requirements, and will support audits and regulatory inspections as a system expert.

Requirements

Bachelor’s degree in Engineering, Information Technology, Computer Science, Automation, Electrical Engineering, Chemical Engineering, or a related technical field with 5–8 years of relevant experience; alternatively, an associate degree in a related technical field with 7–10 years of relevant experience.
At least 5 years supporting automation systems in GMP manufacturing environments.
Experience with PLC, SCADA/HMI, historian, industrial control systems, and instrumentation.
Experience leading automation projects, system upgrades, and troubleshooting efforts.
Experience managing change controls, deviations, investigations, and CAPAs.
Experience supporting validated systems within regulated manufacturing environments.
Ability to stand, walk, bend, and climb stairs or ladders regularly throughout the workday.
Ability to lift and carry up to 30 pounds occasionally.
Manual dexterity to operate laptops, tools, instrumentation, and testing equipment.
Ability to visually inspect equipment and read control panels, instrumentation, and technical documentation; corrected vision is acceptable.
Ability to work in tight or awkward spaces, including behind equipment and within cleanroom utility areas, while troubleshooting or supporting projects.
Ability to sit for extended periods while preparing technical documentation, reports, investigations, and engineering deliverables.
Ability to wear required PPE, including safety glasses or goggles, gloves, lab coats, and respiratory protection when required.

Nice To Haves

Experience in biopharmaceutical manufacturing.
Experience in cell and gene therapy.
Experience in vaccine manufacturing.
Experience in CDMO organizations.
Experience in sterile injectable manufacturing.

Responsibilities

Serve as system owner and automation subject-matter expert for manufacturing and facility automation systems.
Troubleshoot production-impacting issues involving PLCs, SCADA/HMI systems, historians, alarms, industrial networks, and OEM equipment.
Support Manufacturing, Facilities, and Utilities teams when automation issues arise; conduct root cause investigations and implement long-term corrective actions.
Provide after-hours escalation support for critical system failures.
Monitor assigned systems’ performance, reliability, and data integrity; identify opportunities to improve uptime, maintainability, cybersecurity, and system effectiveness.
Coordinate with vendors and integrators on system support and upgrades.
Lead automation workstreams for equipment installations and capital projects, including user requirements, design reviews, FAT/SAT, commissioning, qualification, startup, and handoff.
Author and review change controls, deviations, CAPAs, risk assessments, SOPs, technical specifications, and lifecycle documentation.
Ensure systems remain compliant with cGMP, GAMP, and data integrity requirements.
Support audits and regulatory inspections as the system subject-matter expert.
Mentor Automation Engineers I and II, review technical work, and lead cross-functional technical discussions.
Coordinate activities with Quality, Validation, MS&T, Operations, Facilities, and Engineering teams.