Senior Manager Automation

Regeneron Pharmaceuticals; Limerick; Sur place; EUR 87 000 - 141 000; Plein temps

Résumé du poste

Regeneron Pharmaceuticals in Limerick is seeking a Sr Manager Automation to lead the IT PMO and Business Operations team onsite. The role oversees configuring and installing biopharmaceutical equipment, mentoring OT engineers, and coordinating automation services to ensure data integrity and compliance.

Collaboration with Validation, Manufacturing, QC and Maintenance is essential for successful operations. The position emphasizes leadership, regulatory readiness, and lifecycle management of OT

Qualifications

• BS/BA in Science, Engineering or Software Programming and 8+ years of experience (5+ years supervisory)
• Knowledge of cGMP biotech/pharma operations, regulatory and quality policies, documentation methods
• Understanding of Software Design Lifecycle and Quality Risk Management
• Demonstrated project management expertise
• Ability to resolve complex inter-departmental issues
• Ability to influence leaders in cross-functional roles regarding automation solutions

Responsabilités

• Build and lead a team of OT engineers/specialists; provide mentoring, performance management and career development
• Ensure training, development and compliance of direct reports and subordinate staff
• Coordinate configuration and support of laboratory and process equipment
• Act as Subject Matter Expert during regulatory inspections and internal investigations
• Manage projects related to process equipment and laboratory software automation
• Lead workflow within automation Support groups; set priorities and vet requests for automation services
• Partner with Validation by providing technical personnel for equipment configuration and qualification
• Support regulatory compliance and quality systems through audits and process improvements
• Collaborate with Manufacturing, QC and Maintenance as a technical advisor
• Ensure data integrity for manufacturing and testing data
• Own OT equipment architecture and lifecycle management
• Lead investigations and CAPAs related to OT system deviations, outages or data integrity events
• Manage OT-related budgets, vendor relationships and service contracts

Connaissances

Leadership

Project management

Regulatory compliance

Automation knowledge

Interdepartmental collaboration

Formation

BS/BA in Science, Engineering or Software Programming

Description du poste

Build our future together:

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.

When & where:

• Location: Raheen, Limerick

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

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.

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.

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)

€86,800.00 - €141,200.00