Senior Automation Engineer

Catalent Pharma Solutions LLC; United States; Presencial; USD 120.000 - 140.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Onsite location

Medical, dental, vision benefits

8 paid holidays

Tuition reimbursement

PTO

Descripción de la vacante

Catalent, Inc. is seeking a Senior Automation Engineer to own and optimize automated manufacturing systems at our Harmans, MD site. You will troubleshoot PLCs, SCADA/HMI, historians, alarms, and networks while coordinating vendor support for upgrades.

This role requires leadership in automation workstreams and hands-on QC/compliance oversight. You will mentor junior engineers, maintain data integrity, and ensure systems stay compliant with cGMP and data integrity standards.

Formación

• Bachelor’s degree in Engineering or related field required.
• 5–8 years of relevant experience in automation engineering.
• GMP manufacturing environment experience preferred.
• Experience with PLC, SCADA/HMI, historian, and instrumentation.
• Experience leading automation projects and changes.
• Experience with change controls, deviations, investigations, and CAPAs.
• Ability to work onsite and wear PPE when required.

Responsabilidades

• Own automation systems and lead troubleshooting for manufacturing and facilities.
• Coordinate vendor/integrator support for upgrades and changes.
• Lead automation workstreams for equipment installs and capital projects (UR, FAT/SAT, commissioning).
• Develop and review change controls, deviations, CAPAs, risk assessments, and SOPs.

Conocimientos

PLC systems

SCADA/HMI

Historians

Troubleshooting

Change controls

CAPA

Leadership

Educación

Bachelor’s degree in Engineering

Associate degree in related technical field

Herramientas

None specified

Descripción del empleo

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.

The Candidate 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. 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 [e-mail]. This option is reserved for individuals who require accommodation due to a disability.

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.

Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to [e-mail] for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.

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.

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life‑cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life‑enhancing and life‑saving treatments for patients annually.