Senior Automation Engineer

Catalent; Harmans (MD); Sur place; USD 120 000 - 140 000; Plein temps

Avantages offerts par ce poste

Medical, dental and vision benefits

Tuition Reimbursement

8 paid holidays

Résumé du poste

Catalent, Inc. is seeking a Senior Automation Engineer in Harmans, MD, onsite. The role leads troubleshooting of PLCs, SCADA/HMI, historians, alarms, and networks, and drives automation workstreams for major changes and capital projects. You will mentor junior engineers and ensure cGMP compliance.

Requires 5–8 years in GMP automation, strong project leadership, and experience with change controls and CAPAs. Excellent collaboration with Quality and Validation teams is essential.

Qualifications

• Bachelor’s degree or Associate degree with relevant experience in GMP environments.
• 5+ years supporting automation systems in GMP manufacturing.

Responsabilités

• Serve as system owner and automation SME.
• Troubleshoot PLC/SCADA/HMI, historians, alarms, and networks.
• Lead automation workstreams for capital projects and changes.
• Author/change controls, deviations, CAPAs, and lifecycle docs.

Connaissances

PLC

SCADA/HMI

Historians

Automation projects

Change controls

Regulated environments

Troubleshooting

Root cause investigations

Formation

Bachelor’s degree in Engineering or related field

Associate degree in related field

Outils

SCADA/HMI

Historians

Industrial networks

Alarms

Description du poste

About Site

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.

About Site

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.

Position Summary

We have an opportunity for a Senior Automation Engineer to join our team supporting automated and computerized systems used in manufacturing and Facilities and Utility operations. This role leads complex troubleshooting, owns assigned systems, and manages automation workstreams for major changes and capital projects. The Senior Automation Engineer also mentors less-experienced engineers and ensures systems operate reliably and compliantly. The position reports to the Senior Manager, Automation Engineering.

Shift: Monday - Friday 8am-5pm

Location: Harmans, MD - BWI

100% Onsite

The Role

• Serve as system owner and automation subject-matter expert ensuring reliable operation of 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 and perform root cause investigations with long-term corrective actions.
• Provide after-hours escalation support for critical system failures.
• Act as technical owner for assigned automation systems, monitoring 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.

Minimum Requirements

• Bachelor’s degree in Engineering, Information Technology, Computer Science, Automation, Electrical Engineering, Chemical Engineering, or related technical field with 5–8 years of relevant experience, or Associate degree in a related technical field with 7–10 years of relevant experience.
• 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, read control panels, instrumentation, and technical documentation (corrected vision acceptable).
• Ability to work in tight or awkward spaces, including behind equipment and within cleanroom utility areas when troubleshooting or supporting projects.
• Ability to sit for extended periods while preparing technical documentation, reports, investigations, and engineering deliverables.
• Must be able to wear required PPE, including safety glasses/goggles, gloves, lab coats, and respiratory protection when required.

Preferred Skills & Background

• Biopharmaceutical manufacturing
• Cell & Gene Therapy
• Vaccine manufacturing
• CDMO organizations
• Sterile injectable manufacturing

Pay

The anticipated salary range for this position in MD is $120,000 – $140,000 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.

Why You Should Join Catalent

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• Competitive paid time off + 8 paid holidays
• Community engagement and green initiatives
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement

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.

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 [e-mail]. 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.

Volunteer Work Disclosure: Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis.

Massachusetts Lie Detector Test Notice: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.