Senior Specialist, QC Equipment

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 Bristol Myers Squibb is seeking a Senior Specialist, QC Equipment Qualification and lifecycle management, at Cell Therapy Facility (CTF) in Leiden, The Netherlands. The QC Sr. Specialist Equipment Qualification is responsible for qualification, calibration and maintenance of Quality Control equipment in support of analytical and microbiology QC laboratories. This includes, but is not limited to, interfacing with QC method SMEs, Site Engineers, Facilities, and vendors to facilitate and leading in equipment lifecycle management, including qualification, calibration, maintenance and decommission activities. The Sr. Specialist role is stationed in Leiden and reports to the Head of CTF QC Systems. Job Responsibilities: Serves as the QC equipment system owner and manages the lifecyle activities of QC laboratory equipment, including: Support creation of equipment User Requirement, IOPQ protocols. Collaborating with QC laboratories, Site Engineering, Facility Services and other departments for the commissioning and decommissioning of laboratory equipment. Schedule, facilitate and participate in performing the qualification, calibration, maintenance, repairs of QC laboratory equipment, whether performed internally or by vendors. Maintain equipment records in accordance with GMP requirements and written procedures. Maintain electronic equipment database, equipment logs, equipment status metrics, and applying equipment status labels. Providing basic and first-line equipment troubleshooting. Providing training to laboratory personnel on equipment calibration and maintenance processes, as applicable. Overseeing QC activities related to equipment change management. Assisting management with investigations and deviations related to equipment. Performs other tasks as required to support the QC laboratories. Qualifications and Education Requirements Advanced competency and experience in QC instrument qualification in GMP environment. Working knowledge of Biomolecular, Analytical and Microbiology laboratory equipment such as Flow Cytometry, PCR, BSCs, BacT, Plate reader, etc. and ability to perform basic equipment troubleshooting is desirable. Knowledge of GMP regulations and Ability to accurately and completely understand, follow, interpret, and apply global regulatory and GMP requirements. Detail-oriented with expertise in problem solving and solid decision-making abilities. Ability to work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects. Ability to work with management locally and globally. Strong written and verbal communications skills and interpersonal skills; Advanced ability to communicate effectively with peers, department management and cross-functional peers Working knowledge of Data Integrity is desired. Bachelor’s degree required, preferably in chemistry, microbiology, or related science. 6 + years of relevant experience, preferably in a regulated environment. Experience with current Good Manufacturing Practices (cGMPs) and 21 CFR 210/211. Experience and understanding of biological manufacturing processes and aseptic technique a plus. An equivalent combination of education and experience may substitute. 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.