Senior Manager, OT Automation & Lab Systems (Onsite)

Regeneron Pharmaceuticals, Inc.; Raheen Business Park; Sur place; EUR 140 000 - 190 000; Plein temps

Résumé du poste

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

Responsabilités

• 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

Connaissances

Leadership

Project management

Cross-functional influence

Data integrity

Formation

BS/BA in Science/Engineering or Software

Outils

Automation systems

Process equipment

GxP/CGMP

Description du poste

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.