Global CSV (Computer System Validation) Specialist
Location: Bornem
TheGlobal CSV Specialistplays a key role within theQuality Assurance organization, closely supporting the IT/OT organization by qualifyingandvalidatingthe global IT/OT infrastructure and systems landscape.
The roleis responsible forcoordinating and executing Computer System Validation activitiesensuringcomputerized systemscomplywithinternal and external regulationsand best practices inPharma/Life Sciences GMP environment. This includes developing, communicating, and implementing adequateQuality, Qualification and Validationstandards and procedures for IT/OT infrastructureand applications, and related service providers.
TheGlobal CSV specialist not onlyprovides expertconsultationto 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 andmonitorsthe implementation of corrective and preventive actions. Additionally, the position supports supplier audits for IT/OT components, systems and services.
Whatyouwillget:
1. An agile career and dynamic working culture
2. Aninclusiveandethicalworkplace
3. Compensation programs that recognize high performance
4. A variety of benefits dependent on role and location
5. The full list of our global benefits can be also found on.
Whatyouwilldo:
6. Ensure proper GMPrelated standards for IT/OT infrastructure, systems and services (software and hardware) are developed and defined, and support the evaluation of new systems toestablishqualification requirements.
7. Ensure that data integrity policies and measures for IT/OT infrastructure and systems are in place and implemented.
8. Coordinate qualification and validation and ensure thatappropriate actionsare carried out and recordedin accordance withapproved documented procedures, regulatoryrequirementsand Corporate Quality Standards.
9. Ensure that qualification and validation requirements are communicated effectively to IT/OT, Centers of Excellence, Business Functions,QAand other relevant personnel, including System Owners.
10. Provide quality oversight of the global IT/OT infrastructure and systems (including outsourced components,systemsand service providers), including change control, deviation/CAPA handling, testing, patchmanagementand periodic review.
11. Act asexpert(SME) for internal and external audits, agency inspections and customer audits, and support supplier audits for IT/OT components,systemsand services.
12. Train sites and project teams in the respective procedures and standardsandcollaborate 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.
13. Support the IT/OT organization in developing and applying the global change management process for new or changed infrastructure components,processesor systems.
What we are looking for:
14. BSc in IT, OT, (Bio-)Informatics, Engineering, orrelatedtechnical discipline.
15. 5 - 10 years relevant experience in IT/Engineering
16. 0 - 4 years relevant experience in Quality / Compliance
17. Analytical thinking, adaptability, and solid knowledge ofIT/OT systems,Infrastructure,Quality Management Systems (QMS),andvalidationoflifecycle processes,along with experience in training and sharing best practices.
18. Strong coordination skills, clear communication, and the ability to work across globalteams
19. Excellentverbal and written communication skills in English.
20. Willingness to travel (up to 10%).
21. There is no visa sponsorship available for this role
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.
People come to Lonza for the challenge and creativity of solving complex problems and developingnew ideasin life sciences. In return, we offerthe satisfactionthat comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
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.
Reference: R73754