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 unimageable with us.
The ideal candidate will have extensive experience in FDA 21 CFR Part 11, EU Annex 11, GVP regulations, and GAMP GxP computerized systems validation. Familiarity with the ISPE GAMP AI Guide, AI Guidance for GxP environments, and the EU AI Act will add additional value. The candidate should also possess a solid understanding of Agile development under GxP conditions, act and decide risk based and strengthen this mindset within the team.
Your Role
- Lead and manage the validation activities for R&D IT systems, ensuring compliance with regulatory guidelines (e.g., FDA, EMA) and internal policies.
- Develop and implement validation strategies, plans, and documentation (e.g., URS, IQ, OQ, PQ) for new and existing systems.
- Collaborate with cross-functional teams, including IT, Quality Assurance, and R&D, to ensure seamless integration of validation processes into project timelines.
- Conduct risk assessments and gap analyses to identify validation needs and ensure compliance throughout the system lifecycle.
- Provide expert guidance and support during audits and inspections related to validation activities.
- Mentor and train team members on validation best practices and regulatory requirements.
- Stay current with industry trends, regulations, and technologies related to IT system validation.
- Prior hands-on experience on validating SaaS applications is mandatory.
Who You Are
- Bachelor's degree in computer science, Life Sciences, Engineering, or a related field; advanced degree preferred.
- Minimum of 5 years of experience in IT system validation within the pharmaceutical or biotechnology industry.
- Strong knowledge of international GxP regulations, validation methodologies, and risk management principles.
- Proven experience in leading validation projects and managing cross-functional teams.
- Excellent communication, problem-solving, and organizational skills.
- Ability to work independently and collaboratively in a fast-paced environment
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 those impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!
