Position Overview
The Measurement and Reference Equipment Specialist is responsible for the effective management and coordination of measurement and calibration devices at the Schaffhausen site. The role ensures that devices are properly recorded, maintained, calibrated and documented throughout their entire lifecycle, in compliance with applicable GMP requirements, internal guidelines and technical standards.
The position works closely with Engineering, Maintenance, Production, Quality, and external calibration service providers.
Main Responsibilities
•Management of measurement and calibration devices at the site throughout their entire lifecycle.
•Maintenance of correct device and calibration master data, including relevant data in SAP PM and associated systems.
•Coordination and monitoring of planned calibration activities, due dates, and processing status.
•Ensuring that measuring devices have a valid calibration status and are suitable for their intended purpose.
•Coordination of internal and external calibration activities as well as external service providers.
•Review and management of calibration certificates and associated technical documentation.
•Assessment and handling of Out-of-Tolerance (OOT) cases and calibration-related deviations.
•Handling investigations, non-conformances and CAPAs related to calibrations or measuring devices.
•Ensuring that calibration activities comply with applicable GMP requirements, site guidelines and approved calibration strategies.
•Creation and continuous improvement of calibration plans, calibration intervals and maintenance strategies.
•Ensuring transparency regarding device status, overdue activities and relevant KPIs.
•Introduction, modification, replacement and decommissioning of measuring devices.
•Acting as technical point of contact for Engineering, Maintenance, Production and Quality for calibration and measurement technology questions.
•Identifying opportunities for standardization, digitalization and process improvement in the area of calibration and measurement device management.
•Responsible during audits and inspections by providing complete and correct calibration records and technical documentation.
Qualifications
•Technical training or degree in Engineering, Automation, Electrical Engineering, Mechanical Engineering, Measurement Technology, or a comparable technical field.
•Experience with measuring devices, instrumentation, calibration or maintenance in a regulated environment.
•Understanding of GMP requirements and corresponding documentation requirements.
•Experience with SAP PM or comparable computerized maintenance management systems is an advantage.
•Good understanding of calibration principles, measurement ranges, tolerances, acceptance criteria and metrological traceability.
•Structured and highly precise way of working.
•Strong coordination and communication skills.
•Ability to collaborate cross-functionally with Engineering, Maintenance, Production, Quality and external service providers.
•Good communication skills in German and English.
Key Interfaces
•Maintenance & Reliability
•Engineering
•Production
•Quality Assurance
•Validation / Qualification
•Automation
•External calibration service providers
