Senior Specialist, Digital Plant Laboratory

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 Ireland Bristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units Located in Dublin, Cruiserath Biologics Campus, a one billion Multi-Product Cell Culture Biologics Manufacturing facility plays a central role in the Global Product Development and Supply (GPS) network as the company’s first European biologics manufacturing facility. This state of the art facility will produce multiple therapies for the company’s growing biologics portfolio. Global Biologics Laboratory (GBL) responsible for the release testing of Biologics Drug product for the network, is also based on the Cruiserath Biologics Campus. BMS Cruiserath has been awarded “Biopharma Company of the Year 2019” in the Irish Pharma Industry Awards and is certified as a Great Place to Work since 2017, including as a Great Place to Work for Women in 2020 and 2021. For more information about Bristol Myers Squibb, visit us at BMS.com/ie The Role BMS Cruiserath Biologics is seeking to recruit a permanent Senior Specialist, Digital Plant Laboratory. The BMS facility in Cruiserath, Dublin, includes QC Separations, Bioassay, Manufacturing Science & Technology, and Analytical Sciences & Technology Laboratories, for the global release of Drug Product and the local manufacture of Drug Substance. This position of a Senior Specialist, Digital Plant Laboratory is required to support, and reports to the BMS Digital Plant Laboratory manager to meet the day to day business needs. They will provide ongoing operational support of, and the introduction of new, Instrument Systems in the Laboratories at Cruiserath. They will work closely with Quality Assurance, Quality Control, Computer System Validation and IT functions to ensure the ingoing operation and compliance of the laboratories systems for Cruiserath. This permanent position reports to the BMS Digital Plant (DP) Laboratory Manager. Key Duties and Responsibilities: Provide support to the team of DP Laboratory Engineers for Lab sustaining activities. Ensure KPI’s to track performance are in place and reported on to drive business improvement. Ensure that all work on Lab IT and Benchtop Analytical equipment is carried out in a compliant manner, meets 21 CFR Part 11, EU Annexe 11, cGLP/GMP’s, and Corporate & local BMS compliance requirements. Day to day compliance support of IT Laboratory Systems including User Access Reviews, system performance monitoring, change control, data management. Support the maintenance of AIT systems in a state of Audit Readiness. Management of IT lifecycle procedures including change management, incident management, disaster recovery. Ensure the AIT processes/procedures meet the business and site Quality Management System requirements and their evolution/improvement to meet the changing business and compliance needs. Support the introduction of new instrument systems. Work with all departments, QA, QC, CSV, Engineering, and with contract vendors. Qualifications, Knowledge and Skills Required: Degree in Engineering, Information Systems, Computer Science or Life Sciences. At least 4 years’ experience of working in a pharmaceutical laboratory environment, with IT experience of laboratory instrument systems. Experience of working in GMP Quality Management Systems in laboratory or manufacturing environment. Ability to keep work pace and meet deadlines. Good organising and planning skills. Strong leadership, communication skills, critical thinking, and customer management skills. Proven success working well in a team environment with flexibility to react to changing business needs. Ability to anticipate, evaluate and resolve multiple, simultaneous operational issues. Ability to work independently and remotely with minimum direct supervision. Thorough knowledge of Pharmaceutical Industry Regulations (cGMP/cGLP, OSHA, EPA/EQB), 21 CFR 11 and EU Annex 11 as they relate to Lab IT systems. What’s important to us Employees are expected to display the BMS Values, which move us toward our mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases: Passion: Our dedication to learning and excellence helps us to deliver exceptional results. Innovation: We pursue disruptive and bold solutions for patients. Urgency: We move together with speed and quality because patients are waiting. Accountability: We all own BMS’ success and strive to be transparent and deliver on our commitments. Integrity: We demonstrate ethics, integrity and quality in everything we do for patients, customers and colleagues. Inclusion: We embrace diversity and foster an environment where we can all work together at our full potential. We have a passion for tackling the toughest diseases, which inspires innovation and speed in our daily work and a sense of accountability to the patients we serve. Why you should apply You will help patients in their fight against serious diseases You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees. You’ll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical allowance, 23.5 days annual leave plus 3 Company days, life assurance, on-site gym and gain-sharing bonus. BMSBL
LI-Onsite 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.