Clinical API Technologist - Continuous Manufacturing

Pfizer; Ireland; On-site; EUR 60,000 - 85,000; Full time

Job summary

Pfizer is seeking a Technologist for the Ringaskiddy Clinical Manufacturing Facility (RCMF) to support continuous processing and new product introductions. The role works in cross-functional process teams and travels to observe and transfer processes.

You will develop and execute manufacturing techniques for clinical API products, aiming for safety, quality, cost efficiency, and continuous improvement. The position reports to the Operations Lead.

Qualifications

• Experience in API/biopharma manufacturing or food processing is required.
• NFQ Level 7+ qualification in pharma, biopharma, chemical/process or mechanical engineering or equivalent.
• Experience with API continuous manufacturing is advantageous.
• Strong technical, problem-solving and communication skills.
• Ability to perform in a dynamic, performance-driven environment.

Responsibilities

• 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 required in 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.
• Leading and supporting investigations 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
• Participate and excel in the RCMF technologist rotations programme.

Skills

API/biopharma manufacturing experience

NFQ Level 7+ qualification

Continuous manufacturing

Problem solving

Communication skills

Education

NFQ Level 7+ in Pharma/Biopharma/Chemical/Process/Mechanical Engineering

Job description

Pfizer is seeking a Technologist for the Ringaskiddy Clinical Manufacturing Facility (RCMF) to support continuous processing and new product introductions. The role works in cross-functional process teams and travels to observe and transfer processes.

You will develop and execute manufacturing techniques for clinical API products, aiming for safety, quality, cost efficiency, and continuous improvement. The position reports to the Operations Lead.