Qualification, Equipment Validation & CSV Expert
Grünenthal Visualizza tutti gli annunci
- Origgio, Varese
- Tempo indeterminato
- Full time
- Be part of Global Operations multidisciplinary group dealing with plant engineering, automation and applications
- Support digital roadmap implementation and engineering/production project
- Application of global engineering standards, best practices to the manufacturing sites
- Provide scientific engineering solutions to problems in Global Manufacturing with focus on operations excellence and KPI satisfaction
- Taking care of utilities/equipment/computerized System Validation lifecycle (e2e)
- Support in managing the inventory of computerized systems of the plant, undertake an evaluation of the risk and propose mitigations
- Ensure top-level helpdesk of ERP (i.e. SAP), MES, serialisation and/or computerized systems of competence
- Dynamic interaction with internal and external customers to drive innovation
- University degree Biotechnologies, Engineering, IT or comparable
- Minimum 3 years-experienced with validation, CSV in Pharma or comparable
- An experience in a coordination role (e.g. project manager, coordinator, team leader) would be beneficial
- Knowledge of validation techniques (GMP; GAMP; WHO, CFR21…), risk management, data management, data integrity knowledges
- OPEX problem solving techniques is beneficial
- Interpersonal understanding, communication skills, leadership attitude
- Fluency in business English
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