Computer System Validation Professional for Confidance® Validation Services

Computer System Validation (CSV) Professional<br><br><br><br>Join Sartorius as a Senior Computer System Validation (CSV) Professional and become a key player in driving harmonization, compliance, and quality assurance within our Confidence® Validation Services Quality team. In this impactful role, you will lead the establishment of a harmonized validation policy, ensuring our computer systems are compliant with the latest regulatory standards (e.g., 21 CFR Part 11, OECD 17, OECD 17 supplement 1, EU-GMP Annex 11). Your expertise will be instrumental in implementing state-of-the-art tools such as an eQMS and ELN/LIMS, enhancing our service department's efficiency and quality. Additionally, you will have a chance to elevate our quality assurance processes by driving the implementation of an eQMS as well as to contribute to the global harmonization across all Confidence® Validation Services sites. This full-time hybrid position offers the flexibility of remote work while requiring some on-site presence to foster collaboration and innovation.<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p><b><span>Your Key Responsibilities</span></b></p><p></p><ul><li><p><b>Lead the Development and Implementation:</b> Spearhead the creation and execution of a comprehensive computer system validation policy, ensuring alignment with current regulatory standards (e.g., 21 CFR Part 11, OECD 17, OECD 17 supplement 1, EU-GMP Annex 11, GAMP 5) for Confidence® Validation Services.</p></li><li><p><b>Drive Global Electronic Systems Initiatives:</b> Lead the implementation of new global electronic systems, such as an eQMS, ensuring seamless integration and compliance.</p></li><li><p><b>Post-Implementation:</b> Manage the ongoing maintenance and updates of electronic systems, ensuring optimal performance and compliance.</p></li><li><p><b>Risk Assessment and Compliance:</b> Conduct risk assessments, compile compliance reports, manage deviations, and ensure all documentation meets quality and regulatory standards.</p></li><li><p>Create and oversee CSV protocols, including IQ, OQ, and PQ, ensuring thorough validation of electronic systems.</p></li><li><p>Oversee the document lifecycle, from creation and revision to storage</p></li><li><p>Support administration of electronic systems ensuring efficient operation</p></li><li><p>Offer basic CSV training to enhance team capabilities and ensure compliance</p></li><li><p>Collaborate intimately with all stakeholders to guarantee systems comply with project and regulatory standards</p></li><li><p>Participate in regular project meetings to align with system owners and management, ensuring project requirements are met and issues are resolved.</p></li><li><p>Supervise vendor interactions, including reviewing and tracking vendor deliverables and system qualifications</p></li><li><p>Collaborate with global/regional site quality units and functions to ensure harmonized practices</p></li><li><p>Any ad hoc duties to collaborate and contribute to other activities as identified Confidence® management</p></li></ul><p></p><p><b><span>What will convince us </span></b></p><ul><li><p><b>Advanced Educational Background:</b> Master&#39;s degree or higher in a relevant field (e.g., Engineering, Computer Science, Life Sciences)</p></li><li><p><b>Industry Experience:</b> Minimum of 5 years in a GMP and/or GLP-regulated environment, with a proven track record in validating cloud solutions such as eQMS, LIMS/ELN, and stand-alone computer systems.</p></li><li><p><b>Regulatory Expertise:</b> Extensive knowledge of CSV regulatory requirements (e.g., 21 CFR Part 11, OECD 17, OECD 17 supplement 1, EU-GMP Annex 11, GAMP 5).</p></li><li><p><b>Independent Deliverable Generation:</b> Ability to independently generate CSV deliverables, ensuring high-quality outputs.</p></li><li><p>Experience in working in a cross-cultural set up</p></li><li><p>Ability to develop realistic work plans, set personal goals that align with company goals</p></li><li><p>Superior organizational, communication, and documentation skills</p></li><li><p>Self-driven and methodical way of working, ensuring thoroughness and accuracy</p></li><li><p>Fluent in English, with excellent communication skills</p></li></ul><p></p><p><b>About Sartorius </b></p><p></p><p>Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide. </p><p></p><p>We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment.</p><p></p><p>Join our global team and become part of the solution. We are looking forward to receiving your application. <br /><a href="https://www.sartorius.com/careers" target="_blank">www.sartorius.com/careers</a></p>