Qualification, Equipment Validation & CSV Expert
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Department: Global Operations & Production
Job ID: 45087
Our people inManufacturing & 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
Grünenthal is a global leader in pain management and related diseases. As a science-based, privately-owned pharmaceutical company, we have a long track record of bringing innovative treatments and state-of-the‐art technologies to patients worldwide. Our purpose is to change lives for the better – and innovation is our passion. We are focussing all of our activities and efforts on working towards our vision of a world free of pain.
Grünenthal is headquartered in Aachen, Germany, and has affiliates in 28 countries across Europe, Latin America and the US. Our products are available in more than 100 countries. xrdztoy In 2024, Grünenthal employed around 4,300 people and achieved sales of € 1.8 billion.