Overview
Technologist — Ringaskiddy Clinical Manufacturing Facility (RCMF)
The RCMF is a multi-product clinical API manufacturing facility enabled for continuous processing using FAST platforms. It combines existing clinical workflow capabilities with advanced technology to support a small-molecule API portfolio. The facility will scale up clinical products developed in our CRD laboratories in the U.S. and will tech transfer successful products from RCMF to Ringaskiddy commercial production facilities.
Reporting to the Operations Lead, Technologists work in Process Teams aligned with new product introduction workflows and continuous manufacturing technologies. They contribute to delivering a fully operational facility focused on safety, quality, supply and cost, and will pursue continuous improvement, skill development, and personal growth. Travel may be required to observe new processes and participate in on/off-site meetings.
Purpose: Breakthroughs that change patients’ lives. Pfizer is patient-centric and pursues a digital transformation to accelerate drug discovery and development, while maintaining a diverse and inclusive workforce. Pfizer is an equal employment opportunity and disability inclusion employer.
Responsibilities
* Independently prioritise and schedule activities to meet RCMF manufacturing requirements
* Support manufacturing schedule by working shift patterns as needed
* Execute flawless manufacturing operations in line with safety, quality and customer service metrics for clinical campaigns
* Understand and use manufacturing control systems to execute processing steps
* Assemble, disassemble and clean process equipment for changeovers
* Maintain audit-ready housekeeping standards
* Adhere to quality and safety procedures
* Monitor and optimise product quality and yield; improve process efficiency, quality and safety
* Observe processes and technologies in Pharm Sci Kilo lab facility
* Prepare RCMF readiness for new product activity following startup plans
* Perform real-time data analysis and support data-driven decisions with Pharm Sci colleagues
* Lead and support investigations of process problems; compile data and technical reports
* Lead post-campaign reviews and participate in cross-functional teams to achieve RCMF goals
* Assist with preparing manufacturing documentation (SOPs, batch books, etc.)
* Complete personal training; participate in equipment commissioning and qualification activities
* Provide training and support to new RCMF staff
* Co-lead technical transfer of processes to Ringaskiddy commercial facilities
* Develop relationships with PGS New Products Value Stream to support tech transfer
* Coordinate with New Products Technology Laboratory (NPTL) for alignment
* Prepare for safety and quality inspections; support knowledge transfer to Ringaskiddy
* Drive continuous improvement of RCMF workflows and permit-related activities
* Additional duties as required by the business
Qualifications / Selection Criteria
* Relevant experience in API/biopharma manufacturing or food processing
* At least NFQ level 7 qualification 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
* Proven performance in a dynamic operating environment with emphasis on flawless execution
* Ability to work effectively in a highly competent team and adapt to startup challenges
* Strong interpersonal skills, teamwork, attention to detail; open, collaborative communication
* Ability to take initiative and respond to business needs
* Problem solving and experience with technology transfer is advantageous
Job Details
* Work Location: Onsite
* Work Type: Full-time (4-cycle shift role)
* Application Closing date: 21 October
* Authorisation to live and work in Ireland is required
* Additional information: legal eligibility to work in Ireland; no relocation assistance
How to Apply
* Submit your CV; we look forward to hearing from suitable candidates
Legal and Inclusivity
Pfizer is committed to equal employment opportunity and disability inclusion. We encourage applicants of all backgrounds and will consider reasonable adjustments to support your application and career.
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