Computer System Validation Specialist

Work Your Magic with us!  

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Your role:

We have an exciting opportunity as a Computer Systems Validation (CSV) Specialist within our Livingston site.  You will lead Computer Systems Validation (CSV) across the site and support the execution of the Validation Master Plan. You will ensure compliance with regulatory requirements (21 CFR parts 11, 211, 600, ISO 9001, ISO 13485) and provide guidance on validation issues. Participate in investigations for failures, CAPA, and continuous improvement initiatives while maintaining and updating validation procedures.

Stay informed on the latest regulatory requirements and support the IT department in Software and Hardware Validation compliance. Act as a subject matter expert (SME) for GxP systems, driving compliance strategies and managing GxP system life cycle activities, including change management and system integration projects.

Who you are:

•    Bachelor’s/Undergraduate Degree in a quality or science-related discipline (chemistry, biology, or medical technology preferred).
•    Significant amount of experience in Computer Systems Validation.
•    Expertise in GMP, FDA regulations, SOP development, and understanding of Validation and Data Integrity Principles.
•    Strong analytical and problem-solving skills, with the ability to present results effectively.
•    Proficient in Microsoft Word, Excel, and PowerPoint.
•    Excellent written and verbal communication skills, capable of collaborating at all organizational levels.
•    Ability to work well in a team, taking accountability for actions and contributing to team objectives.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!