Shift Lead, Manufacturing Operations (cGMP)

Mallinckrodt; Dublin; On-site; EUR 70,000 - 90,000; Full time

Job summary

Keenova in Dublin seeks a Manufacturing Operations Shift Lead to guide the shift team at the College Park facility, ensuring production meets safety, quality and schedule targets. You will collaborate with Warehouse, Quality, Engineering and EHS to optimise processes, while conforming to SOPs and cGMP requirements.

The role includes mentoring staff, coordinating workloads, and serving as senior on-site during out-of-hours activity.

Responsibilities

• Ensure timely completion of plant operations, safe operations, attention to detail, and good documentation skills. Directly oversees and participates in daily cGMP operations in a cGMP environment.
• Ensure safety standards and policies are maintained and enforced. Be a role model these expected behaviours
• Coordinate the workload of the shift team in order to meet schedules and timelines.
• Assist in the development of performance goals and objectives for team.
• Mentor and coach team in order to ensure full performance potential.
• Act as interface between management team and functional team.
• Participates in and attends cross-functional (multidiscipline) meetings when required.
• Resolve issues within area of control to ensure smooth running of manufacturing area
• Write deviation notifications when required by cGMP and/or SOP. Coordinate investigations and corrective action follow-up to ensure closure.
• Reviews and approves area procedures, including SOP's, master batch documentation, change controls, and validation protocols/reports.
• Leads project-related working groups (cross-functional) in order to troubleshoot any issues and to generate policies, etc.
• Supports inventory functions occurring in day to day business operations between manufacturing and material management
• Work with the planning and warehouse function to coordinates the timely receipt and/or release of materials to meet production needs.
• Network with all Area Leads and track area progress on key issues.
• Acts as designee / point of contact for Operations Manager when required.
• Acts as senior person on site during out of normal hours activity
• At Keenova, we believe that no one should be alone in their pursuit of better health. This purpose drives us as we pair quality therapeutics with human support-showing up in big moments and small to help patients find comfort and confidence.
• We bring deep expertise and resolve to every therapeutic area we serve, including immunology, urology, men's health, orthopedics, critical care, and pediatric endocrinology. We work with patients, care partners, and physicians to help them navigate healthcare system complexity and access therapies that make a meaningful difference.

Job description

Keenova in Dublin seeks a Manufacturing Operations Shift Lead to guide the shift team at the College Park facility, ensuring production meets safety, quality and schedule targets. You will collaborate with Warehouse, Quality, Engineering and EHS to optimise processes, while conforming to SOPs and cGMP requirements.

The role includes mentoring staff, coordinating workloads, and serving as senior on-site during out-of-hours activity.