Overview
Ringaskiddy Clinical Manufacturing Facility (RCMF) – The RCMF is a multi-product clinical API manufacturing facility enabled for continuous processing using FAST platforms. The design combines existing clinical workflow capabilities with advances in technology and architecture to support a contemporary API clinical facility that will serve the needs of our small molecule portfolio into the future. The RCMF will scale up new clinical products developed in our CRD laboratories at our U.S. research sites (Groton, Connecticut) and will tech transfer successful new products from the RCMF to the Ringaskiddy commercial manufacturing site.
Position and Team
Reporting to the Operations Lead, the Technologist works in Process Teams aligned with new product introduction workflows utilizing cutting edge continuous manufacturing technologies. Technologists are part of a dynamic, highly competent team responsible for delivering a fully operational facility with strong performance in safety, quality, supply and cost. Technologists will develop and execute manufacturing techniques for Pfizer’s newest products and pursue continuous improvement, technical up-skilling and personal development in a performance-driven environment. Travel may be required to observe new processes in transferring facilities and to attend, contribute to and present at on- and off-site meetings as required.
Accountabilities / Responsibilities
* Independently prioritizing and scheduling activities to support business needs and to meet the RCMF manufacturing schedule requirements.
* Working shift patterns to meet business needs and the manufacturing schedule.
* 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, disassembling and cleaning of process equipment as required to support equipment changeover.
* Maintaining housekeeping standards in the manufacturing facility to an audit-ready standard at all times.
* Adherence to all relevant quality and safety procedures.
* Monitoring and optimizing the quality and yield of products, including process efficiency, quality and safety improvements.
* Observation of processes and technologies in the Pharm Sci Kilo lab facility.
* Preparation of RCMF for new product activity from a safety, quality and operational perspective following the start-up Standard Work Plan.
* Real-time data analysis (e.g., Process Analytical Technology data) and real-time decision-making in partnership with Pharm Sci colleagues.
* Leading and supporting investigations and resolution of process problems on plant.
* Data collection, trending and generation of technical reports; leading post-campaign reviews with Pharm Sci colleagues.
* Participating in cross-functional teams to achieve RCMF goals.
* Assisting with writing, reviewing and revising manufacturing documentation (e.g., SOPs, batch books).
* Completing personal training requirements in compliance with site procedures and supporting facility equipment commissioning and qualification activities as part of a development program.
* Providing training and support to new RCMF staff to ensure learning objectives are met.
* Co-leading technical transfer of processes from RCMF to Ringaskiddy commercial production facilities.
* Developing strong relationships with PGS New Products Value Stream (SEG, NPTL) to support tech transfer activities.
* Coordinating with small-scale manufacturing facilities in PGS, particularly the New Products Technology Laboratory (NPTL).
* Readiness for and participation in routine safety and quality inspections.
* Supporting technology and knowledge transfer of new products to the Ringaskiddy New Products Value Stream.
* Continuous improvement of workflows associated with RCMF operations and permitting activities within the facility.
* Additional areas of responsibility as the business requires.
Qualifications / Skills, Knowledge & Experience
* Relevant experience in API/Biopharma manufacturing or food processing.
* At least a level 7 or higher qualification (NFQ framework) in pharma, biopharma, chemical/process/mechanical engineering or equivalent.
* API continuous manufacturing experience is advantageous but not essential.
* Excellent technical, problem-solving and communication skills.
* Consistently high performance in a dynamic operating environment with emphasis on flawless execution and flexibility.
* Ability to work as part of a highly competent, self-motivated team and handle challenges of facility start-up.
* Evidence of high performance in a continuous improvement environment with strong interpersonal skills and attention to detail.
* Ability to foster open, team-based communication to meet business targets.
* Strong leadership, constructive challenge and influence within a team.
* Ability to work on own initiative and respond proactively to business needs.
* Problem identification and solving skills plus experience with technology transfer would be advantageous.
Work Details
Work Location Assignment: Onsite
Work Type: Full-time (4 cycle shift role)
Application Closing date: 21 October (00:00 hours)
All applicants must have relevant authorization to live and work in Ireland.
Additional Information
* Legal eligibility to work in Ireland is required for consideration.
* No relocation support is available for this position.
How To Apply
* Make a difference today — suitable candidates should apply with CV below. We look forward to hearing from you.
Purpose and Values
Breakthroughs that change patients' lives. Pfizer is a patient-centric company guided by courage, joy, equity and excellence. Our breakthrough culture supports transforming millions of lives.
Equal Employment Opportunity & Inclusion
Pfizer is committed to a diverse and inclusive workforce. We celebrate diversity in all forms and strive to build a culture that encourages, supports and empowers our employees. We are a disability-inclusive employer and will make reasonable adjustments to support your application and future career. Your journey with Pfizer starts here.
Manufacturing
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