Job Description
Working with Us Challenging. Meaningful. Life-changing. Those arent 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. Youll 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. 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: . 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 companys first European biologics manufacturing facility. This state of the art facility will produce multiple therapies for the companys 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, 2021 and 2022. Position Summary BMS Cruiserath Biologics is seeking to recruit a permanent Manager, Engineering Commissioning, Qualification and Validation. Reporting to the Associate Director, Engineering Commissioning, Qualification and Validation the successful candidate will initially be part of the Sterile Drug Product Facility (SDPF) project team working within the Lyophilizer CQV team. The candidate will be responsible for the installation and qualification of the lyophilizers used within the SDP facility. Upon completion of the SDPF project, responsibilities will shift to a one campus approach and this role will expand scope to cover CQV activities across drug product and in the drug substance facility. The manager will lead a team of validation specialists, develop and implement validation strategies, and drive continuous improvement initiatives to enhance the efficiency and effectiveness of the sterilization and temperature mapping processes. Key Responsibilities Support the Sterile Drug Product Facility project as part of the CQV team responsible for the Lyophilizer qualification. Plan, coordinate, and oversee validation activities for validation projects, ensuring timely completion and adherence to budgetary constraints. Ensure compliance with relevant regulatory requirements, such as FDA, EMA, and GMP guidelines, as well as internal quality standards and procedures. Conduct risk assessments to identify potential hazards and develop mitigation strategies to ensure the safe and reliable operation of systems and processes. Prepare and review validation protocols, reports, and standard operating procedures (SOPs), ensuring accuracy, completeness, and compliance with regulatory guidelines. Collaborate with cross-functional teams, including MS&T, engineering, quality assurance, regulatory affairs, and manufacturing, to ensure alignment and coordination of validation activities with overall project objectives. Develop and implement change control processes, ensuring that any modifications or upgrades to systems and processes are properly validated and documented. Identify opportunities for process improvement and optimization of validation activities, implementing best practices and innovative approaches to enhance efficiency and compliance. Collaborate with external vendors and contractors to ensure proper installation, qualification, and validation of systems and equipment, including review and approval of vendor documentation. Provide training and mentorship to validation team members, promoting professional growth and development. Support internal and external audits and inspections related to validation activities, ensuring compliance and addressing any findings or observations. Qualifications & Experience The successful candidate must possess a Bachelor/Masters in Engineering, or Science related discipline. Extensive experience in commissioning and qualification activities, including developing and implementing validation strategies, managing validation projects, and ensuring compliance with regulatory requirements. Experience in conducting risk assessments and developing mitigation strategies to ensure the safe and reliable operation of systems and processes. Demonstrated ability to ensure compliance with regulatory requirements and internal quality standards. Proficiency in preparing and reviewing validation protocols, reports, and standard operating procedures (SOPs) with a strong attention to detail. Excellent technical writing skills are essential. Experience collaborating with cross-functional teams, including engineering, quality assurance, regulatory affairs, and manufacturing, to ensure alignment and coordination of validation activities with overall project objectives. Proven ability to identify opportunities for process improvement and optimization of validation activities, implementing best practices and innovative approaches to enhance efficiency and compliance. Experience supporting internal and external audits and inspections related to validation activities, including addressing findings or observations and implementing corrective actions. Previous experience with a biologics startup facility and a good understanding of systems such as Delta V, MES, SAP is desired. 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. Youll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical allowance, 27 days of annual leave, life assurance and on-site gym Skills: Manager Engineering Commissioning Qualification and Validation