Qualification, Equipment Validation & CSV Expert

Qualification, Equipment Validation & CSV Expert

Grünenthal Group

Origgio, Italy

What the job looks like

Each day you'll enjoy a variety of challenges, such as:

• 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

What you'll bring to the table

To make the most of this role and truly thrive, you should have:

• 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