Manager Process Validation

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. Bristol Myers Squibb Netherlands Bristol Myers Squibb has been active in the Dutch market for over 50 years, employing people across a range of activities and business units in Utrecht, The Netherlands. The Netherlands is also home to our first European Cell Therapy facility, located at the Leiden Bio Science Park, the largest life sciences cluster of The Netherlands. This new state of the art facility is focused on commercial manufacturing with capabilities for multi-product Cell Therapy manufacturing. You can become part of this exciting journey. Check out this video if you want to know more about it! The Netherlands has everything it takes to become the medicines hub of Europe, the so-called Boston by the North Sea. As we continue to expand our footprint by building this new site, we are looking to grow our team. Would you like to become an important chain in our worldwide network to bring this new personalized treatment to patients suffering from blood cancer? Join us and be a game changer! For more information about Bristol Myers Squibb Netherlands, visit us at bms.com/nl or careers.bms.com/nl Position Summary The Manager Process Validation is responsible for managing site process related validation activities and reports to Sr. manager/AD validation. This function is responsible for the validation studies through the life cycle and supports implementation and execution of the CAR-T processes at Leiden site. This function acts as SME on validation studies, including APS and Process validation and presents these activities to the authorities during an audit. He/She collaborates with SMEs from the Process Engineering, MES/Automation, Manufacturing, and Quality to ensure rapid, flawless, compliant, and cost-effective delivery of quality products. Key Responsibilities Maintain permanent inspection readiness and actively support regulatory inspections. Foster a culture of compliance and strong environmental, health, and safety performance Support the tracking of team metrics and manage completion of objectives and projects Continuously monitor, analyze, and optimize the end-to-end process and anticipate and permanently resolve issues that may arise during the activities Support related investigations, ensuring compliance with internal standards and regulatory requirements Qualifications & Experience Bachelor’s degree in relevant science or engineering discipline, or equivalent in work experience. Advanced degree preferred. Knowledge of process engineering or process validation required Knowledge of Lean Manufacturing principles required. Minimum of 7 years of experience in cGMP biologics manufacturing, preferably in cell therapy 2+ years supervising staff in a management role Disclaimer: For any third parties or external agencies, please, be informed we do not accept unsolicited requests, proposals, applications or profiles for any of our roles at BMS. Why You Should Apply Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.