Senior Manager Automation

Regeneron; Raheen Business Park; On-site; EUR 140,000 - 190,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in Limerick, Ireland, is seeking a Senior Manager Automation to lead the IT PMO and Business Operations team onsite. You will oversee OT engineers, ensure data integrity, and drive equipment configuration, qualification and software automation projects.

The role requires 8+ years in biotech/pharma with supervisory experience, cGMP knowledge, and strong cross-functional influence. Onsite collaboration with Manufacturing, QC and Maintenance is essential.

Qualifications

• BS/BA in Science, Engineering or Software; 8+ years experience with 5+ years supervisory
• Knowledge of cGMP biotech/pharma operations and regulatory quality policies
• Understanding of software Design Lifecycle and Quality Risk Management
• Proven project management experience and cross-functional issue resolution
• Strong ability to influence leaders across departments regarding automation solutions
• Experience with regulatory inspections and CAPAs related to OT systems

Responsibilities

• Build and lead a team of OT engineers/specialists with mentoring and career development
• Ensure training, development and compliance of direct reports
• Coordinate configuration and support of laboratory and process equipment
• Act as SME during regulatory inspections and internal investigations
• Manage projects related to process equipment and laboratory software automation
• Lead automation support workflow and prioritize requests for services
• Partner with Validation for equipment configuration and qualification
• Support regulatory compliance and quality systems through audits
• Collaborate with Manufacturing, QC and Maintenance as technical advisor
• Ensure data integrity for manufacturing and testing of drug product
• Own OT equipment architecture and lifecycle management
• Lead investigations and CAPAs for OT deviations or data integrity events
• Manage OT-related budgets, vendor relationships and contracts

Skills

Leadership

Project management

Cross-functional influence

Data integrity

Education

BS/BA in Science/Engineering or Software

Tools

Automation systems

Process equipment

GxP/CGMP

Job description

Team: Industrial Operations & Product Supply

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Sr Manager Automation to join our IT PMO and Business Operations team in Limerick in an onsite position.

In this role, you will oversee the group responsible for the configuration and installation of new biopharmaceutical process and manufacturing laboratory equipment while collaborating with personnel in the Automation Department.

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

Discover your role:

• Building and leading a team of OT engineers/specialists; providing mentoring, performance management, and career development
• Responsible for ensuring training, development, and compliance of direct reports and subordinate staff
• Coordinating activities related to configuration and support of laboratory and process equipment
• Acting as a Subject Matter Expert during regulatory inspections and internal investigations
• Managing projects related to process equipment and laboratory software automation
• Leading the workflow within automation Support groups; setting priorities and vetting requests for automation services
• Partnering with the Validation Department by providing technical personnel for configuration and qualification of equipment
• Supporting the regulatory compliance and efforts through audit participation and quality systems development
• Collaborating with Manufacturing, QC and Maintenance as a technical advisor
• Ensuring integrity is maintained for data generated during manufacturing and testing of drug product
• Owning the architecture and lifecycle management of OT equipment
• Leading investigations and CAPAs related to OT system deviations, outages, or data integrity events
• Managing OT-related capital and operational budgets, vendor relationships, and service contracts

This role requires:

• Requires BS/BA in Science, Engineering or Software Programming and 8+ years of experience (5+ years of supervisory experience)
• Current knowledge of cGMP biotech/pharma operations, industry trends, regulatory and quality policies, procedures and documentation methods
• Solid understanding of software Design Lifecycle and Quality Risk Management
• Demonstrated project management expertise
• Proven capability in resolving complex inter-departmental and organisational issues
• Strength in influencing leaders in cross-functional roles regarding automation solutions

#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.

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)

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