Senior Manager Automation

Regeneron is seeking a Sr Manager Automation to join the IT PMO and Business Operations team in Raheen, Limerick (onsite). The role oversees the group responsible for configuration and installation of new biopharmaceutical process and manufacturing laboratory equipment while collaborating with the Automation Department.

Responsibilities

• Building and leading a team of OT engineers/specialists; providing 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 regulatory compliance 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

Requirements

• 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

Benefits

• Annual bonuses or other incentive plans
• Equity awards
• Pension or retirement benefits
• 401(k) company match
• Health and wellness programs
• Fitness centers
• Insurance benefits (medical, dental, vision, life and disability)
• Paid time off
• Family support benefits

Pay

Salary range disclosed for Canada: 86,800.00 – 141,200.00 annually. Final offer determined based on country of employment, specific role level, skills and experience; collective bargaining agreements may apply in some countries.

Schedule

Onsite position in Raheen, Limerick. Regeneron expects many roles to be performed onsite; specific expectations discussed with recruiter and hiring manager.