Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

What Makes This Opportunity Unique

At Thermo Fisher Scientific Inc., Lengnau, we are committed to innovation and excellence. As a CSV & DI officer, you will play a pivotal role in ensuring our computerized systems validation (CSV) framework and processes are innovative. Your work will contribute to a world-class compliance lifecycle approach, improving our site's GMP and Data Integrity standards. This position offers an ambitious individual the chance to lead, train, and mentor staff, while collaborating closely with Execution Systems, Engineering Quality team, supply chain, manufacturing and Quality Control.

Job ResponsibilitiesCoordinate the Site’s CSV framework and processes, ensuring flawless validation activities.Establish and maintain the GMP and Data Integrity training.Coordinate / participate to the on-the-floor Data Integrity (DI) Gemba and provide mentoring to DI champions.Ensure timely reporting of Data Integrity concerns to the Site Leadership team and implement mitigation actions based on the approved Site Masterplan.Owner of the DI site KPIs.Represent the Lengnau Site in global Data Integrity networks and initiatives.Ensure regulatory compliance associated with CSV and contribute to regulatory submissions, responses, and inspections.

RequirementsDegree in Information Technology, Engineering or Life Sciences (Biology, Chemistry, etc.), Dipl. lng. or M.Sc. or B.Sc. or equivalent.Proven experience in coordinating computerized systems validation (CSV) and data integrity in operations.Able to lead staff by example, providing technical support and mentoring.Strong understanding of GMP regulations and validation practices.Outstanding skills in training and mentoring staff on compliance frameworks.Ability to strictly adhere to regulatory requirements and successfully implement necessary actions.Excellent communication and collaboration skills to work effectively with cross-functional teams.Self-motivated with a track record of contributing to regulatory submissions and inspections.

Why Join Us?

Join us in our mission to make the world healthier, cleaner, and safer. At Thermo Fisher Scientific, you will work in an inclusive environment that values diverse experiences and perspectives. Be part of an ambitious team that strives for excellence and innovation every day. This is your opportunity to contribute to groundbreaking scientific advancements and help support patients globally!