Qualification, Equipment Validation & CSV Expert

Our people in Manufacturing & Global Operations share two priorities: getting things done and making things better. If you’re a dynamic person with a positive mindset, you’ll fit in well here. It’s an international team with a powerful spirit of collaboration. Together, we make sure our products meet the highest standards of quality by constantly searching for ways to improve at every stage of our value chain – from the raw materials we buy through to the logistics network that brings our medicines to patients. Join our team and help us make an even bigger contribution to Grünenthal’s future.

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