Principal Automation Engineer

Regeneron Pharmaceuticals, Inc.; Limerick; On-site; EUR 63,000 - 103,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in Limerick seeks a Principal Automation Engineer to join the Automation team. You will lead end-to-end automation projects, act as SME for Allen-Bradley PLC systems, and drive change control and regulatory compliance in a fast-growing bioscience environment.

You will collaborate with cross-functional teams, support 24/7 operations, and mentor junior engineers while upholding high engineering and quality standards aligned with GAMP 5 and cGMP regulations.

Qualifications

• BS/BA in Science or Engineering with 8+ years in validated automation systems.
• Solid knowledge of GMP regulations and 21 CFR Part 11 requirements.
• Hands-on experience with Rockwell/Allen-Bradley platforms and data systems.

Responsibilities

• Serve as SME for Allen Bradley Rockwell PLC and HMI programming, diagnostics and troubleshooting.
• Lead end-to-end automation projects from concept to turnover.
• Develop and maintain project schedules with cross-functional teams.
• Own change control for automation configurations; protect data integrity.
• Provide design documentation guidance and test plans for cGMP equipment.
• Lead root cause analyses and complex troubleshooting for automation systems.
• Deliver 24/7 on-call support as required.
• Drive continuous improvement of production operations and system performance.
• Oversee automation contractors to ensure quality and compliance.
• Own design and approval of hardware, software, and controls.

Skills

Automation leadership

Regulatory compliance

GMP knowledge

21 CFR Part 11

Root cause analysis

Project management

Education

BS/BA in Science/Engineering

Tools

Allen Bradley Rockwell PLC

FactoryTalk View Studio SE/ME

ControlLogix Studio 5000

FactoryTalk Historian

SEEQ

Ignition

Splunk

MS SQL

Job description

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking a Principal Automation Engineer to join our Automation team.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

• Location: Limerick

What you’ll do:

• 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
• Offering 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
• Delivering 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

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. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

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