Senior Scientist, Sterilization Validation, Sterile Drug Product Manufacturing, Science & Technology

<p><b>Working with Us</b><br/>Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.</p><p></p><p>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. Read more: <a href="https://careers.bms.com/working-with-us" rel="noopener noreferrer" target="_blank"><span><span><span><span><span><span>careers.bms.com/working-with-us</span></span></span></span></span></span></a>.</p><p></p><p></p><p><b>Bristol Myers Squibb Ireland</b></p><p></p><p>Bristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units</p><p>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.</p><p>BMS Cruiserath has been <span>awarded “Biopharma</span> 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, 2021 and 2022.  </p><p><br/><b>Position Summary</b></p><p></p><p>BMS Cruiserath Biologics is seeking to recruit a permanent <b>Senior Scientist, Sterilization Validation, Sterile Drug Product Manufacturing, Science &amp; Technology.</b> Reporting to the Associate Director Process Engineering, Sterile Drug Product Manufacturing, Science &amp; Technology, this role will be the Validation Lead for all sterilization aspects of equipment being installed in a new Sterile Drug Product Manufacturing Facility being built on the Cruiserath campus.  You will be part of a multi-functional team charged with the delivery of the significant capital investment and will be accountable for all sterilization validation aspects of the process equipment. Upon completion of the project, you will continue to support the sustaining operation on site as well as acting as a global Subject Matter Expert (SME) within the organization.<br/><br/><b>Key Responsibilities</b></p><ul><li>Develop a strategy to ensure that the validation approach for the new SDP facility satisfies the requirements of all regulatory bodies; regulations, standards, guidance and GMP, including effective and appropriate use of process development.</li><li>Development and execution of allocated validations according to the SDP Validation Master Plan.</li><li>Produce and maintain appropriate and comprehensive validation policies and procedures.</li><li>Act as lead for all technical and equipment validation activities from design to successful PPQ of products within the SDP facility, and after which will support routine production of the facility.</li><li>Ensure that the design, installation and operation of Plant and Equipment have been validated in compliance with current regulatory requirements.</li><li>Provide input, monitor, and report compliance on the content of the Validation Master Plan in conjunction with the appropriate Primary teams, and corresponding Management Reviews.</li><li>Ensure the review and approval of validation lifecycle documentation and ensure they are written in accordance with the company standards and procedures.</li><li>Develop and maintain processes and procedures to ensure product tech transfers are achieved efficiently.</li><li>Manage the activities of a defined team of Validation Engineers. Management responsibilities to include day to day work allocation and prioritisation of work, performance and output quality review, coaching, training, internal communications, and general personnel assistance during their duties.</li><li>Draft and approve test protocol and reports as required along with supporting the execution of IQ/OQ and PQ activities for SDP during start up as required.</li><li>Publish site specific progress reports as required.</li><li>Quality of completed validations [Effectiveness, schedule adherence, minimum deviations]</li><li>Validation