Principal Automation Engineer

Regeneron Ireland; Limerick; On-site; EUR 63,000 - 103,000; Full time

Job summary

Regeneron Ireland in Limerick is seeking a senior automation engineer to act as SME for Allen Bradley Rockwell PLC, HMI programming, diagnostics and troubleshooting across validated automation systems.

You will lead end-to-end automation projects from concept through commissioning, own change control and documentation, ensure GMP compliance, and provide 24/7 on-call support as required.

Qualifications

• BS/BA in Science/Engineering with GMP/cGMP experience
• 8+ years experience with validated automation systems
• Strong knowledge of 21 CFR Part 11 and GAMP 5 and validation/qualification methodologies
• Experience with Allen Bradley Rockwell platform (FactoryTalk View Studio SE/ME, ControlLogix) and data analytics tools

Responsibilities

• Serve as SME for Allen Bradley Rockwell PLC and HMI programming and diagnostics
• Lead end-to-end automation projects from concept to commissioning and turnover
• Own change control processes and ensure data integrity throughout the lifecycle
• Provide on-call 24/7 support and drive continuous improvement in production operations

Skills

Leadership

Regulatory compliance

Cross-functional collaboration

Communication skills

Analytical troubleshooting

On-call support

Education

BS/BA in Science/Engineering

Tools

FactoryTalk View Studio SE/ME

ControlLogix Studio 5000

FactoryTalk Historian

SEEQ

Ignition

MS SQL

Job description

When & where: Location: Limerick

• Serving as the site's subject matter expert for Allen Bradley Rockwell PLC and HMI programming, diagnostics, and troubleshooting, ensuring robust and reliable performance of automated process equipment
• Leading end-to-end automation engineering projects, taking ownership from concept and design through execution, commissioning, and turnover
• Developing and maintaining detailed, accurate project schedules while collaborating with cross-functional teams, end users, and third-party partners to design, develop, document, and maintain software architecture deliverables for both embedded and application software
• Taking ownership of change control processes for automation system configuration changes, ensuring rigorous adherence to established SOPs, thorough assessment of impact to Manufacturing and Facilities equipment, and preservation of data integrity throughout the change lifecycle
• Providing expert guidance on engineering design documentation, technical evaluations, and test plans for cGMP process equipment, ensuring strict compliance with GAMP 5 guidelines and applicable GMP regulations
• Leading root cause analysis, incident investigations, and complex troubleshooting for automation systems, driving issues to resolution with a high degree of independence and accountability
• Providing out-of-hours (24/7) on-call support as required to maintain operational continuity
• Driving continuous improvement of production operations, identifying and delivering opportunities to enhance system performance, reliability, and compliance
• Providing leadership and oversight in the management of automation contractors, ensuring quality and compliance standards are upheld throughout engagements
• Owning the design and approval of hardware, software, and controls for automated equipment, upholding rigorous engineering and quality standards

The environment and physical rhythms of this role:

Demonstrated leadership capability, with a proven track record of working independently, exercising sound judgement without direct supervision, and mentoring junior members of the automation team Strong compliance mindset with a proactive, disciplined approach to audit readiness and regulatory inspection support Excellent cross-functional collaboration and communication skills, with the ability to build strong working relationships across departments and with external business partners

Let’s find out if we’re a fit:

BS/BA in Science/Engineering discipline and a minimum 8 years experience working with validated Automation systems within a regulated industry (e.g., FDA/cGMP), with demonstrated expertise in GMP regulations and compliance frameworks

Strong working knowledge of 21 CFR Part 11, GAMP 5, validation/qualification methodologies, data integrity principles, and change control processes

In-depth, hands‑on experience with the Allen Bradley Rockwell automation platform (FactoryTalk View Studio SE/ME, ControlLogix Studio 5000, FactoryTalk Historian, etc.)

Familiarity with complementary data management and analytics platforms (e.g., SEEQ, Ignition, Splunk, MS SQL) considered a strong advantage

Thrive today. Grow tomorrow.

#IRELIM #JOBSIEST #LI-Onsite

Does this sound like you?

We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship. Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. Please be advised that at Regeneron, we believe we do our best work when we are together. As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications. For jobs in Canada: this posting is for an existing position. Salary Range (annually) €63,200.00 - €103,200.00 Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.