Description

<div><div>Global CSV (Computer System Validation) Specialist </div><div> </div><div>Location: Bornem </div><div> </div><div>The Global CSV Specialist plays a key role within the Quality Assurance organization, closely supporting the IT /OT organization by qualifying and validating the global IT/OT infrastructure and systems landscape.The role is responsible for coordinating and executing Computer System Validation activities ensuring computerized systems comply with internal and external regulations and best practices in Pharma/Life Sciences GMP environment. This includes developing, communicating, and implementing adequate Quality, Qualification and Validation standards and procedures for IT/OT infrastructure and applications, and related service providers. </div><div> </div><div>The Global CSV specialist not only provides expert consultation to IT/OT projects on the correct application of regulatory requirements, but also actively executes validation and qualification activities. This includes hands-on support such as: writing test cases, managing deviations and contributing directly to project deliverables. The role offers quality oversight of global IT/OT systems, including the evaluation of changes, deviations and periodic reviews. The role also conducts audits of IT infrastructure and systems in collaboration with Global GMP Compliance and monitors the implementation of corrective and preventive actions. Additionally, the position supports supplier audits for IT/OT components, systems and services. </div><div> </div><div>What you will get: </div><div><ul><li>An agile career and dynamic working culture </li></ul></div><div><ul><li>An inclusive and ethical workplace </li></ul></div><div><ul><li>Compensation programs that recognize high performance </li></ul></div><div><ul><li>A variety of benefits dependent on role and location </li></ul></div><div><ul><li>The full list of our global benefits can be also found on <a href="https://www.lonza.com/careers/benefits" target="_blank">https://www.lonza.com/careers/benefits</a>. </li></ul></div><div> </div><div>What you will do: </div><div><ul><li>Ensure proper GMP related standards for IT/OT infrastructure, systems and services (software and hardware) are developed and defined, and support the evaluation of new systems to establish qualification requirements. </li></ul></div><div><ul><li>Ensure that data integrity policies and measures for IT/OT infrastructure and systems are in place and implemented. </li></ul></div><div><ul><li>Coordinate qualification and validation and ensure that appropriate actions are carried out and recorded in accordance with approved documented procedures, regulatory requirements and Corporate Quality Standards. </li></ul></div><div><ul><li>Ensure that qualification and validation requirements are communicated effectively to IT/OT, Centers of Excellence, Business Functions, QA and other relevant personnel, including System Owners. </li></ul></div></div><div><div><ul><li>Provide quality oversight of the global IT/OT infrastructure and systems (including outsourced components, systems and service providers), including change control, deviation/CAPA handling, testing, patch management and periodic review. </li></ul></div><div><ul><li>Act as expert (SME) for internal and external audits, agency inspections and customer audits, and support supplier audits for IT/OT components, systems and services. </li></ul></div><div><ul><li>Train sites and project teams in the respective procedures and standards and collaborate with global quality personnel to develop global policy and a common approach to compliance with applicable regulations and best practice, including support for the global change management process. </li></ul></div><div><ul><li>Support the IT/OT organization in developing and applying the global change management process for new or changed infrastructure components, processes or systems. </li></ul></div><div> </div><div>What we are looking for: </div><div><ul><li>BSc in IT, OT, (Bio-)Informatics, Engineering, or related technical discipline. </li></ul></div><div><ul><li>5 - 10 years relevant experience in IT/Engineering </li></ul></div><div><ul><li>0 - 4 years relevant experience in Quality / Compliance </li></ul></div><div><ul><li>Analytical thinking, adaptability, and solid knowledge of IT/OT systems, Infrastructure, Quality Management Systems (QMS), and validation of lifecycle processes, along with experience in training and sharing best practices. </li></ul></div><div><ul><li>Strong coordination skills, clear communication, and the ability to work across global teams </li></ul></div><div><ul><li>Excellent verbal and written communication skills in English. </li></ul></div><div><ul><li>Willingness to travel (up to 10%). </li></ul></div><div><ul><li>There is no visa sponsorship available for this role </li></ul></div><div> </div><div>Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. </div><div> </div><div>People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. </div><div> </div></div><div>Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law. </div>

Global Computer System Validation Specialist

Description

Lonza

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