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AKKA Life Sciences provides assistance to major sector in the chemical, pharmaceutical and biotechnologies industries. The Life Sciences sector is developing fast, aware of the complex challenges in which our clients are facing, the AKKA group offers consultancy and engineering in the field of Health sector.
As part of our pharmaceutical business, we are looking for a
The Subject Matter Expert (SME) Calibration is responsible for supporting all the calibration activities for the Luterbach manufacturing site. She/he provides a high level of technical expertise needed to support daily calibration activities, operations team and equipment related issues during manufacturing campaigns, in full compliance with Safety, Quality, and Compliance. The campus of Luterbach consists of a Central Utilities Building, Warehouse, manufacturing building BMC’s, and related supporting buildings and equipment’s.
The SME Calibration is the point of contact and the expert on the Solothurn site for all calibration activities. The responsibilities include – but does limited to:
- Support all the calibration activities linked to manufacturing and tracks calibration systems through the DeltaV / AMS control systems
- Actively participate to technical training for technicians and assist junior personnel in the completion of scheduled and corrective calibrations
- Define, specify and evaluate necessary modifications to improve operational performance and compliance
- Ensure all safety incidents are properly investigated and corrective/preventative actions are implemented and conducts audits through the mechanical spaces to ensure no adverse events or near miss have occurred, and identify risks situation
- Investigate instruments failures / out of tolerance (Remedial Action Reporting) and serves as system expert for troubleshooting instruments and repairs
- Participate to instrumentation criticality risk assessment, CMMS data, hierarchy, calibration strategy
- Oversee accuracy and improvements to the calibration management database CMMS to ensure consistency, compliance with internal procedures and overall cGMP compliance
- Participate in cross site calibration benchmarking and improvement meetings, communicates across internal departmental lines
- Degree in Automation or within the calibration field, with additional trainings on the processes (temperature, pression…)
- Proven experience and knowledge in calibration, measurement technology, and controls with delta V / AMS system.
- First experience on mid-sized and major projects for Instrumentation with high complexity in the chemical, biotech-or pharmaceutical industry
- Excellent communication skills (written and spoken) in English
- Team player, able to shift priorities and willing to take part in a start up project
- You are solution-oriented, at ease within a complex international environment