Senior Specialist, Computer Systems Validation Engineer

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 Senior Specialist, Computer System Validation Engineer on a fix term contract of one year to support changes to validated systems on site and to support introduction of new computerised systems to the site. The Computer System Validation Engineer will report into the Computer System Validation Manager on progress on assigned tasks and assist in the update of the governing CSV documentation aligned with corporate and regulatory guidelines. Key Duties and Responsibilities: Responsibility for assigned CSV validation projects and informing CSV manager of progress against defined timelines. Creating and executing protocol test scripts in accordance with cGMP, regulatory requirements, the Computer System Validation Master/Project Plan, and Policies, Procedures & Guidelines to ensure robust tested systems, which are fit for use. Assisting in audit preparation and presentation of the above systems for internal, vendor and regulatory audits. Drafting and approval of CSV documentation for system upgrades, changes and general validation challenges, and providing support in identifying the need for creation/updating operating procedures or templates. Updating CSV operational procedures and performing peer review of documentation and additional duties as required by management. Responsible for performing Computerised system periodic reviews across the site and ensuring defined timelines are achieved. Qualifications, Knowledge and Skills Required: The ideal candidate should hold a minimum of a BS qualification (Degree) in a scientific, IS/IT, technical or engineering discipline along with 2+ years of experience in validation at biologics manufacturing operations. A background in validation of computerized system in biologics manufacturing sites is desired. Knowledge of requirements for design, installation, Commissioning, Qualification and Validation of computerized systems using risk-based approaches. Knowledge of regulatory validation requirements including FDA (21 CFR part 11), EMA (Annex 11), ISPE (GAMP 5) and all other Worldwide Regulatory requirements (ICH Q7, Q8, Q9) 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-Hybrid 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.