Senior Automation Engineer
About The Position
Catalent is hiring a Senior Automation Engineer to support automated and computerized systems used in manufacturing, Facilities, and Utilities operations at its Harmans/BWI campus in Maryland. The role serves as system owner and automation subject-matter expert, leading complex troubleshooting and automation workstreams for major system changes, equipment installations, and capital projects. It also mentors less-experienced engineers and helps ensure systems operate reliably and compliantly. The position is based 100% onsite at the Harmans, Maryland facility and reports to the Senior Manager, Automation Engineering. The scheduled shift is 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.
Requirements
- Bachelor’s degree in Engineering, Information Technology, Computer Science, Automation, Electrical Engineering, Chemical Engineering, or a related technical field and 5–8 years of relevant experience; alternatively, an associate degree in a related technical field and 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.
- 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 & 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 with automation issues and conduct root-cause investigations with 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 for 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.
Benefits
- Competitive paid time off and 8 paid holidays.
- Medical, dental, and vision benefits effective on the first day of employment.
- Tuition reimbursement.
- Potential for career growth on an expanding team.
- Defined career path and annual performance review and feedback process.
- Community engagement and green initiatives.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
