Onsite OT Automation Lead for Biotech Lab Systems

Regeneron Pharmaceuticals, Inc.; Limerick; Presencial; EUR 87.000 - 141.000; Jornada completa

Descripción de la vacante

Regeneron Pharmaceuticals, Inc. in Limerick seeks a Sr Manager Automation to lead anOT engineering team, overseeing configuration and installation of laboratory and process equipment in an on-site capacity.

You will mentor staff, drive training and compliance, manage automation projects, and collaborate with Validation, Manufacturing, QC, and Maintenance to ensure data integrity and robust OT architecture across the manufacturing life cycle.

Formación

• 8+ years of experience in automation/IT operations within biotech/pharma.
• Current knowledge of cGMP biotech/pharma operations, regulatory and quality policies.
• Solid understanding of software Design Lifecycle and Quality Risk Management.
• Demonstrated project management expertise.
• Proven capability in resolving complex inter-departmental issues.
• Ability to influence leaders in cross-functional roles regarding automation solutions.

Responsabilidades

• Building and leading a team of OT engineers/specialists; mentoring, performance management, and career development.
• 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.

Conocimientos

Team leadership

Mentoring

Performance management

Career development

Project management

Regulatory inspections

Quality systems

Data integrity

Cross-functional influence

OT systems

Vendor management

Budget management

Educación

BS/BA in Science, Engineering or Software Programming

Descripción del empleo

Regeneron Pharmaceuticals, Inc. in Limerick seeks a Sr Manager Automation to lead anOT engineering team, overseeing configuration and installation of laboratory and process equipment in an on-site capacity.

You will mentor staff, drive training and compliance, manage automation projects, and collaborate with Validation, Manufacturing, QC, and Maintenance to ensure data integrity and robust OT architecture across the manufacturing life cycle.