Senior Automation & OT Leader, Biopharma IT/PMO

Regeneron Pharmaceuticals; Limerick; On-site; EUR 87,000 - 141,000; Full time

Job summary

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

Responsibilities

• 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

Skills

Leadership

Project management

Regulatory compliance

Automation knowledge

Interdepartmental collaboration

Education

BS/BA in Science, Engineering or Software Programming

Job description

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