Ringaskiddy Clinical Manufacturing Facility (RCMF)
Position Summary The RCMF facility is a multi-product clinical API manufacturing facility enabled for batch manufacturing and continuous processing using our FAST platforms. The design is focused on combining existing capabilities from our clinical workflows with the very best advances in technology and architecture to build a truly contemporary API clinical facility which will support the needs of our new products small molecule portfolio into the future. The RCMF is part of Chemical Research and Development (CRD), within Pharmaceutical Sciences Small Molecule (PSSM), part of the Pfizer Research and Development (PRD) organisation. The RCMF will scale up new clinical products developed in our CRD laboratories at our research sites in the U.S. (Groton, Connecticut) and will tech transfer successful new products from the RCMF to our commercial manufacturing site in Ringaskiddy.
Reporting to the Operations Lead, the Technologist works in Process Teams that are aligned with new product introduction workflows utilising cutting edge continuous manufacturing technologies. Technologists are members of a dynamic, highly competent, engaged team of colleagues responsible for delivering a fully operational facility with excellent performance across the fundamentals of safety, quality, supply and cost. Technologists will develop and execute manufacturing techniques consistent with the requirements of Pfizer's newest products, and will be committed to continuous improvement, technical up-skilling and personal development in a performance-driven environment. Technologists will be required to travel periodically to observe new processes in transferring facilities; attend, contribute to and present at on and off-site meetings as required.
The accountabilities of the Technologist position include: Independently prioritizing and scheduling activities to support business needs and to meet requirements of the RCMF manufacturing scheduleWorking shift patterns to meet business needs and the manufacturing schedule as requiredFlawless RCMF manufacturing execution against safety, quality and customer service metrics for clinical campaigns conducted within the facilityUnderstanding and use of manufacturing control systems to execute processing stepsAssembling and disassembling of process equipment, as required in support of equipment changeoverEnsuring that housekeeping standards in the manufacturing facility are maintained to an audit-ready standard at all timesAdherence to all relevant quality and safety proceduresMonitoring and optimizing the quality and yield of the products including optimization of the process with regard to efficiency, quality and safety.Observation of processes & technologies in Pharm Sci Kilo lab facilityPreparation of RCMF for new product activity from a safety, quality and operational perspective through adherence to the start-up Standard Work PlanReal-time analysis of data (e.g. Process Analytical Technology data) and real-time decision-making in partnership with Pharm Sci colleaguesLeading and supporting investigation and resolution of process problems that may occur on plantCollection of data, trending and generation of technical reportsLeading post-campaign reviews with Pharm Sci colleaguesParticipating in cross-functional teams leading to accomplishment of RCMF goals.Assisting with writing, review and revision of manufacturing documentation as necessary e.g. standard operating procedures, batch books etc.Completion of personal training requirements in compliance with site procedures and using facility equipment commissioning and qualification activities as part of a comprehensive learning and development programProviding training and support to new staff members of the RCMF team to ensure that learning objectives are met.Co-lead technical transfer of processes from RCMF to Ringaskiddy commercial production facilitiesDevelop strong relationships with PGS New Products Value Stream (SEG, NPTL) to support tech transfer activitiesOperational alignment with the small-scale manufacturing facilities in PGS, in particular the New Products Technology Laboratory (NPTL)Readiness for and participation in routine safety and quality inspectionsSupport the technology and knowledge transfer of new products to the Ringaskiddy New Products Value StreamContinuous improvement of the workflows associated with the RCMF operationPermitting activities within the RCMFAdditional areas of responsibility as the business requiresSELECTION CRITERIA Qualifications/Skills, Knowledge & Experience: At least 3-5 years relevant experience in either API/ Biopharma manufacturing, Food Processing or Med-TechHave at least a level 7 or higher (NFQ framework) qualification in pharma, biopharma, chemical/process/ mechanical engineering or equivalentAPI continuous manufacturing experience while not essential would be advantageousExcellent technical, problem-solving and communication skillsPerformance at a consistent level of excellence in a consistently dynamic operating environment, where the focus will be on flawless execution and demonstrate flexibility to get the job doneComfortable as part of a highly competent and self-motivated team, and will have the ability to deal with the challenges that a facility start-up may presentDemonstrated evidence of high performance in a continuous improvement-oriented work environment. Excellent interpersonal skills, team orientation and attention to detailFacilitation of an environment of open and team-based communication where all members of the Process Team work together to ensure that business targets are metStrong ability to lead, challenge and positively influence in an interactive team environmentDemonstrated ability to work on own initiative and proactively respond to business needsProblem identification and solving skills plus experience with technology transfer would be an advantageAdditional Information In order to be considered for this position in Ireland you need to be legally eligible to work in Ireland.Please note there is no relocation support available for this position.How to apply Make a difference today, all suitable candidates should apply with CV below. We are looking forward to hearing from you!
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