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 Senior Engineer SME (Equipment Preparation/Formulation), Sterile Drug Product Manufacturing, Science & Technology. Reporting to the Associate Director, Sterile Drug Product Manufacturing, Science & Technology this role will be the Technical Lead for all equipment within and associated with the Equipment Preparation and Formulation areas installed in a new Sterile Drug Product Manufacturing Facility being built on the Cruiserath campus. The successful candidate will be part of a multi-functional team charged with the delivery of the significant capital investment and will be accountable for all technical aspects of this process and 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. Key Responsibilities Technical leadership for new Parts washers, Autoclaves, SUMs (single use mixers) and FITs along with all supporting ancillary equipment within the equipment preparation and formulation areas from Design stage to successful PPQ of all products within the facility, and after which will support routine production of the facility. Ensure that start-up project scope and timelines meet the user requirements and work with the project & CQV teams to facilitate delivery, validation and safe operation of new Parts washers, Autoclaves, SUMs (single use mixers) and FITs and other supporting equipment / processes. Will be acting area SME in support of internal and external audits. Will have an in-depth knowledge of process operations and process equipment to support Manufacturing, Quality, Automation, Validation, and EHS for quality deviation investigation, change controls, and CAPAs. Technical expert for all ancillary equipment and accountable for changes to ensure continued compliance of the manufacturing equipment. Develop and manage projects arising from changes and to improve equipment up times. Generation of scope and budget requirement for any Equipment/Automation improvements/modifications/projects. Ensuring all the systems are in compliance with all Regulatory requirements including Quality (cGDP/GMPs), EHS, Global Engineering, design & construction directives, requirements & procedures, as well as all Local Regulatory requirements. Support Technical Transfers and New Product Introduction. Part of a cross-functional project team, providing key Process/Equipment SME input during design stage and providing engineering support as required, during execution of NPI campaigns. Qualifications & Experience Deep technical knowledge of Sterile Drug Product manufacturing both from a process and equipment perspective. Specifically in the areas of equipment preparation and formulation. Experience on the implementation of new primary packaging components and single use systems within Sterile Drug Product facilities. Knowledgeable on current industry practices and regulatory requirements within the Sterile Drug Product manufacturing area. Familiar with start-up of new Sterile Drug Product manufacturing facility from initial design through to the final qualification of the equipment and process including media fills. First-hand experience of qualification and validation of Sterile Drug Product manufacturing equipment and/or processes. Specifically in the areas of equipment preparation and formulation The successful candidate must possess a Bachelor/masters in engineering, or Science related discipline. A minimum of 5 years experience within a Sterile Drug Product Manufacturing is desirable. Deep and demonstrated understanding and experience of the principles of Annex 1 and how they translate into a contamination control strategy for equipment preparation and formulation areas. Demonstrated ability to influence work cross functionally in a matrix environment during start-up and into commercial manufacture. Experience with Qualification and Validation of new equipment is essential, as well as experience interacting with regulatory agencies. Experience with Technical Transfer of new processes is desirable. The candidate will have demonstrated proficiency communicating and collaborating at a variety of levels, coupled with excellent organization and planning skills. Problem solving and project management ability, as well as lean manufacturing experience is essential. 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: sterile drug product experience planning skills Problem solving and project management ability