New Products Technologists, Pfizer, Cork

• Closing date:17 Feb 2023
• New Products Technologist
  New Products Technology Laboratory (NPTL)
  Pfizer Ringaskiddy API Site, Cork
  Position Summary
  The New Products Technologist role is an exciting and dynamic role helping make new medicines to help patients enhance their lives. The NPTL is a world class manufacturing operation at the Pfizer Ringaskiddy API campus located on the shores west of Cork Harbour and has undergoing significant expansion in the past 12 months with the incorporation of additional capacity, Continuous Manufacturing and a High Potency manufacturing suite which brings Pfizer’s latest APIs from PSSM (Pharmaceutical Sciences Small Molecule) to commercialisation. This involves development of close collaborative working relationships with key stakeholders and Co-Development partners within Pharmaceutical Sciences Research & Development (Pfizer Worldwide R&D), Launch Excellence and Global Technology & Engineering (GTE). The NPTL facility works closely and partners with the Pharmaceutical Sciences Pilot Plant facility at the Sandwich, UK campus.
  Reporting to the NPTL Leader, the Technologist works as part of a larger Process Team that are aligned with the New Product Introduction Value Stream. 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 Pfizer Worldwide R&D facilities; attend, contribute to and present at on and off-site meetings as required.
  The accountabilities of the Technologist position include:
  • Generation of optimal process fits/equipment configuration to meet process needs
  • Participation in Co-Design leading to the design of the optimal API manufacturing process, including the application of innovative technologies
  • Observation of processes & technologies in Pharm Sci Pilot Plant facility
  • Preparation of NPTL for new product activity from a safety, quality and operational perspective through adherence to the NPI start-up Standard Work Plan
  • Flawless NPTL manufacturing execution versus safety, quality/validation and customer service metrics for clinical and launch/validation campaigns conducted within the facility
  • Real-time analysis of data (e.g. Process Analytical Technology data) and real-time decision-making in partnership with Pharm Sci colleagues
  • Adherence to all relevant quality and safety procedures.
  • Monitoring and optimizing the quality and yield of the products including optimization of the process with regard to efficiency, quality and safety using 6 Sigma and Lean manufacturing techniques
  • Leading and supporting investigation and resolution of process problems that may occur on plant using 6 Sigma methodology
  • Collection of data, trending and generation of technical reports
  • Leading post-campaign reviews with Pharm Sci colleagues
  • Independently prioritizing and scheduling activities to support business needs and to meet requirements of the NPTL manufacturing schedule
  • Working shift patterns to meet business needs and the manufacturing schedule as required
  • Participating in cross-functional teams leading to accomplishment of Value Stream and site goals.
  • Assisting with writing, review and revision of manufacturing documentation as necessary.
  • Preparation of documentation related to quality, validation, and process technology (e.g. process validation protocols, standard operating procedures, 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 program
  • Providing training and support to new staff members of the NPTL Team to ensure that learning objectives are met.
  • Understanding and use of manufacturing control systems to execute processing steps
  • Assembling and disassembling of process equipment, as required, in support of equipment changeover
  • Ensuring that housekeeping standards in manufacturing facility are maintained to an audit-ready standard at all times
  • Develop strong relationships with Pharmaceutical Sciences (WRD), Launch Excellence and Global Technology & Engineering – New Products colleagues
  • Operational alignment with the small-scale manufacturing facilities in Chemical R&D, in particular the Sandwich Pilot Plant facility
  • Readiness for and participation in routine regulatory inspections (including new product Pre-Approval Inspections)
  • Support the technology and knowledge transfer of NPI-VS products to the other Ringaskiddy API Value Streams / PGS sites
  • Continuous improvement of the workflows associated with the NPTL facility’s operation through consistent application of Lean / 6 Sigma principles and CI toolkits
  Qualifications
  • At least 3-5 years relevant experience in either API/bio pharma manufacturing, Food Processing or Med-Tech
  • Level 6 or higher (NFQ framework) qualification in pharma, biopharma, chemical/process/ mechanical engineering or equivalent preferential
  • Excellent technical, problem-solving and communication skills
  • Performance 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 done
  • Comfortable as part of a highly competent and self-motivated team, and will have the ability to deal with the challenges that expanded facility start-up may present
  • Demonstrated evidence of high performance in a continuous improvement-oriented work environment. Excellent interpersonal skills, team orientation and attention to detail
  • Facilitation of an environment of open and team-based communication where all members of the Process Team work together to ensure that business targets are met
  • Strong ability to lead, challenge and positively influence in an interactive team environment
  • Demonstrated ability to work on own initiative and proactively respond to business needs
  • Problem identification and solving skills using 6 Sigma / Lean techniques, plus experience with technology transfer would be an advantage

  Work Location Assignment: On Premise

Manufacturing