NPI Process Engineer
Required to develop robust, capable, cost effective & safe manufacturing processes, equipment, materials and products and will support efficient and effective transfer of new products & processes into commercial manufacture.
The successful candidate use strong knowledge and application of process and equipment validation techniques, PFMEA?s, and associated regulatory requirements and applies this knowledge in the efficient & timely validation of equipment and processes.
Responsibilities of NPI Process Engineer:
Leads the development and execution of experimentation and testing to enable characterisation, optimization and troubleshooting of key processes and equipment.
Drive continuous improvement focus, applies lean or six sigma tools in the characterization, optimization and troubleshooting of process equipment and technology performance
Supervises one or more Technicians, managing their technical development and facilitating their daily and project tasks.
Drive lean methodologies, and process improvement tools in the elimination of "waste" process steps and development of efficient, cost effective equipment and processes.
Liaises with Equipment Engineering or external equipment/tooling or material vendors in the selection, design & development of new (or upgrades to existing) equipment, tooling and materials.
Co-ordinates the introduction of new processes, equipment and materials including installation, calibration, EHS assessment debug, and all associated process and quality system documentation requirements including technical and process work instructions.
Completes or leads the writing and release of process validation documentation including FMEA's, Validation Plans, protocols and reports.
Requirements for NPI Process Engineer:
Honours Degree (HETAC Level 8) in Engineering or Science.
3+ years post graduate experience in new product development and/or manufacturing experience in medical / pharmaceutical industries a distinct advantage,
Proven experience in working in cross-functional project teams. Ideally Project Management experience.
Proven experience in process and equipment validation techniques, PFMEA?s, and associated regulatory requirements and application to validation of equipment and processes.
Travel to other sites / vendors as part of Technology development & transfer activities.
Please contact Larry on 01-2302400 / firstname.lastname@example.org
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
Key Words; FDA, GMP, Quality Engineer, Process Engineering, Process Development, Engineering, SPC, Validation, Equipment Validation, NPI, NPD, Pharmaceutical, Medical Device, Biotechnology, Galway, Clare, Munster, West of Ireland, Ireland.