Senior Technologist

Senior Technologist

Ringaskiddy Clinical Manufacturing Facility (RCMF)

Position Summary

The RCMF facility is currently undergoing construction on the Ringaskiddy API site and will be a multi-product clinical API manufacturing facility enabled for 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 Worldwide Research Development and Medicinal Sciences (WRDM) 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 in the UK (Sandwich Kent) and will tech transfer successful new products from the RCMF to our commercial manufacturing site in Ringaskiddy.

Reporting to the Operations Lead the Senior 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. Senior Technologists will develop and execute manufacturing techniques consistent with the requirements of Pfizers newest products and will be committed to continuous improvement technical up-skilling and personal development in a performance-driven environment. Senior 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.

In addition to Technologist responsibilities (below) the Senior Technologists accountabilities also include:

• Responsibility for management of shift colleagues coaching and mentoring
• Technical resource and key decision maker on shift
• Facilitates and supports high levels of safety and quality performance for the shift team
• Provides training (Global Train the Trainer) and mentoring to the shift team
• Monitors adherence to plan identifies delays and implements corrective actions to remediate
• Proactively involved in continuous improvement of plant operations and changeovers
• Executes and monitors processing activities in compliance with cGMP procedures and EHS policies and procedures
• Primary point of contact for emergency response teams
• Primary point of contact for permitting activities especially during silent hours
• Liaise with Ringaskiddy Site Coordinator for out of hours craft support 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 schedule
• Working shift patterns to meet business needs and the manufacturing schedule as required
• Flawless RCMF manufacturing execution against safety quality and customer service metrics for clinical campaigns conducted within the facility
• Understanding and use of manufacturing control systems to execute processing steps
• Assembling and disassembling of process equipment as requiredin support of equipment changeover
• Ensuring that housekeeping standards in the manufacturing facility are maintained to an audit-ready standard at all times
• 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.
• Observation of processes & technologies in Pharm Sci Kilo lab facility
• Co-lead technical transfer of processes from CRD laboratories to CRD Manufacturing
• Generation of optimal process fits/equipment configurations to meet process needs
• Preparation of RCMF for new product activity from a safety quality and operational perspective through adherence to the start-up Standard Work Plan

• Real-time analysis of data (e.g. Process Analytical Technology data) and real-time decision-making in partnership with Pharm Sci colleagues

• Leading and supporting investigation and resolution of process problems that may occur on plant
• Collection of data trending and generation of technical reports
• Leading post-campaign reviews with Pharm Sci colleagues
• Participating 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 program
• Providing 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 facilities
• Develop strong relationships with PGS New Products Value Stream (SEG NPTL) to support tech transfer activities
• Operational 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 inspections
• Support the technology and knowledge transfer of new products to the Ringaskiddy New Products Value Stream
• Continuous improvement of the workflows associated with the RCMF operation
• Permitting activities within the RCMF
• Additional areas of responsibility as the business requires

SELECTION CRITERIA

Qualifications/Skills Knowledge & Experience:

• At least 3-5 years relevant experience in either API/ Biopharma manufacturing Food Processing or Med-Tech
• Have at least a level 7 or higher (NFQ framework) qualification in pharma biopharma chemical/process/ mechanical engineering or equivalent
• API continuous manufacturing experience while not essential would be advantageous
• 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 a 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 plus experience with technology transfer would be an advantage