Senior Validation Specialist

<h2>The position</h2> <p><br/> Joining our company, you will gather an overview of the GBS Enabling Services Organization with a particular focus on the tasks and responsibilities from Validation Management. You will work in a globally operating team that designs, builds and continuously improves Boehringer Ingelheim’s global Processes, using agile principles, methods and tools on a daily basis.<br/> <br/> You will be qualified to contribute to a cross-functional team, and as an MDM Senior Validation Specialist, you will be able to coordinate the activities around change requests, performing impact analysis, reviewing, and approving documents and ensuring a validated state of the system.</p> <h2>Tasks &amp; responsibilities</h2> <ul> <li>Based on your expertise in Computer System Validation, you ensure that changes are managed according to our validation rules in close cooperation with local experts in our GBS user community</li> <li>Acting as a Validation Management Specialist, you support our daily operation of processes and applications</li> <li>You ensure that our processes and systems are always compliant and in a validated state</li> <li>Furthermore, you manage the execution and documentation of testing activities</li> <li>As part of cross-functional teams, you ensure the implementation and continuous improvement of our standardized processes in global projects</li> <li>You are familiar with Agile methods and tools, participating to projects driven with this methodology</li> <li>You are familiar with working in projects and being measured against Key Performance Indicators (KPIs) / Service Level Agreements (SLAs) to strive for continuous improvement measures</li> </ul> <h2>About our future employee</h2> <p>You should speak English fluently and have broad experience in Validation Management, ideally in Computer Systems Validation (CSV).</p> <p>Additionally, we are looking for:</p> <ul> <li>Bachelor’s Degree; preferably in engineering, sciences, pharmaceuticals, or biotechnology or equivalent and longstanding professional experience in regulations and processes</li> <li>Profound experience in a pharmaceutical or biopharmaceutical production or supporting areas (e.g. quality assurance in production) required</li> <li>A strong understanding of pharmaceutical regulations, including those mandated by the FDA, ICH, and European Pharmacopoeia</li> <li>Profound knowledge and understanding of Computer Systems Validation regulation (CSV), including GAMP5, 21 CFR Part 11, CSA framework and EU Annex 11, and Data Integrity regulation</li> <li>Experience in ERP systems (e.g. SAP) is required</li> <li>Experience with Veeva Network would be an asset</li> <li>Experience with agile methods (e.g. SCRUM, Kanban) and tools (e.g. JIRA) would be an advantage</li> <li>Good analytical capabilities and problem-solving competence including a proper understanding of prioritization</li> <li>Dedicated team player with good communication skills, and a structured way of working</li> </ul>