Summary:
Our client, a biopharmaceutical in Carlow, is seeking a Calibration Planner & Scheduler to support and coordinate site-wide calibration and gas detection programmes. The successful candidate will manage the planning, scheduling, coordination and performance of calibration activities across manufacturing, utilities, laboratories, warehouse and support areas. As the main point of contact for calibration planning, they will ensure GMP compliance, maximise equipment availability, optimise external service provider performance and maintain regulatory inspection readiness.
Responsibilities:
- Own the end-to-end planning and scheduling process for site calibration and gas detection activities.
- Develop and maintain weekly, monthly, quarterly, and annual calibration schedules.
- Coordinate calibration activities across manufacturing, laboratories, utilities, warehouse, and support functions.
- Create, plan, release, and manage calibration work orders within SAP and associated maintenance systems.
- Manage calibration backlog and drive timely closure of work orders.
- Coordinate site-wide calibration programmes for instrumentation and gas detection systems.
- Lead the calibration daily meetings and maintain calibration KPI dashboards.
- Manage scheduling and coordination of external calibration vendors.
- Support audit readiness through maintenance of accurate records and planning documentation.
- Manage the lifecycle of instruments.
- Drive improvements in planning, scheduling, and work management processes.
- Demonstrate ownership and accountability for calibration planning performance.
- Influence and support cross-functional initiatives.
- Promote compliance, reliability and operational excellence.
- Comply with applicable policies, procedures and guidelines.
- Perform activities in accordance with current Good Manufacturing Practice (cGMP) requirements.
- Maintain inspection readiness and support regulatory inspections.
- Adhere to data integrity and ALCOA+ principles.
Qualifications & Experience:
- Degree or Level 7 qualification in Engineering, Instrumentation, Maintenance Management or a related discipline.
- A minimum of three years’ experience in planning, scheduling, maintenance, calibration or engineering support within a GMP environment.
- Experience using SAP or an equivalent CMMS/EAM system.
- Experience within pharmaceutical, biotechnology, medical device or regulated manufacturing industries would be preferred.
- Experience with ProCal or an equivalent calibration management system would be preferred.
- Knowledge of GMP, data integrity and regulatory inspection requirements would be preferred.
- Knowledge of instrumentation and calibration practices would be preferred.
- Skills in maintenance planning and scheduling, calibration programme management and SAP/CMMS work management.