Senior Specialist, Engineering Commissioning, Qualification and Validation

<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><span>careers.bms.com/working-with-us</span></span></span></span></span></span></span></a>.</p><p></p><p></p><p><b>Bristol Myers Squibb Ireland</b></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></p><p><b>Position Summary</b></p><p><br/>BMS Cruiserath Biologics is seeking to recruit permanent <b>Senior Specialists, Engineering Commissioning, Qualification and Validation. </b>Specializing in areas such as equipment, utilities and computer systems validation the candidates will report to the Senior Manager, Engineering Commissioning, Qualification and Validation. The successful candidates will initially be part of the Sterile Drug Product Facility (SDPF) project working within the CQV team. Upon completion of the SDP project, responsibilities will shift to a “one campus” approach and this role will expand scope to cover CQV in the drug substance facility. This role involves developing and executing validation protocols, ensuring compliance with regulatory requirements, and supporting continuous improvement initiatives.</p><p></p><p><b>Key Responsibilities</b><br/>•    Support the Sterile Drug Product Facility project as part of the CQV team.<br/>•    Develop and execute commissioning and qualification plans for new and existing equipment and systems.<br/>•    Perform equipment and system start-up activities, including functional testing and troubleshooting.<br/>•    Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.<br/>•    Develop and execute validation protocols to support facility/utilities, equipment and computer systems validation.<br/>•    Ensure that validation activities comply with regulatory requirements (e.g., FDA, EMA, ICH) and industry standards (e.g., GAMP 5).<br/>•    Maintain validation documentation and ensure it is up-to-date and audit-ready.<br/>•    Identify opportunities for process improvements and implement changes to enhance efficiency and compliance.<br/>•    Participate in root cause analysis and <span>corrective/preventive</span> action (CAPA) processes.<br/>•    Work closely with cross-functional teams, including Quality Assurance, Manufacturing, Engineering, and Regulatory Affairs.<br/>•    Communicate validation plans, progress, and results to stakeholders.<br/>•    Provide training and support to team members on CQV processes and procedures.</p><p></p><p><b>Qualifications &amp; Experience</b></p><p>•    Bachelor’s degree in Engineering, Life Sciences, or a related field.<br/>•    Strong knowledge of regulatory requirements and industry standards (e.g., FDA, EMA, ICH, GAMP 5).<br/>•    Experience with risk-based validation approaches and quality risk management.<br/>•    Excellent problem-solving, analytical, and technical writing skills.<br/>•    Strong communication and interpersonal skills.<br/>•    Ability to work independently and as part of a team.<br/>•    Proficiency in Microsoft Office Suite and validation software tools.</p><p></p><p></p><p><b>Why you should apply</b></p><