Manufacturing Process Engineer, NPI
|Contact Name:||Larry O’Leary|
Our client, a medical devices manufacturer based in Galway, now seeks a Manufacturing Process Engineer is responsible for providing technical support to the manufacturing / operations environment (GMP).
The successful candidate will set up a new manufacturing process, managing the successful scale up and commercialisation of this new process ensuring that target yield, capacity, throughput time and productivity are achieved.
Responsibilities of Manufacturing Process Engineer, NPI:
Partner with R&D, Quality and Operations to ensure that the transition of products through R&D, product approval and manufacturing scale up are smooth, timely and cost effective
Design, procure and construct "Lean" production lines taking into account flow optimisation, throughput time, product movement, layout and space.
Specification, Procurement, Installation, and Validation of Manufacturing Equipment, including FAT of equipment.
Set up Preventive Maintenance and Calibration routines.
Lead the knowledge transfer of this new manufacturing process and provide training to product builders and technicians.
Provide ongoing day to day support to Production; continually seek to drive improvement in operation performance while also maintaining highest levels of regulatory conformance.
Develop and execute required validations in line with regulatory requirements to include Equipment, Process & Product validations.
Generate and gain approval for project budgets and subsequently manage expense and capital expenditure in line with this budget.
Requirements for Manufacturing Process Engineer, NPI:
Bachelor's Degree in Engineering or equivalent Degree in a technical discipline.
4+ years' experience in a similar Engineering role in the medical device industry
Strong technical understanding of set up and maintenance of manufacturing processes, experience in validation, equipment design and Lean Manufacturing highly desirable.
Experienced in Product Transfers and Manufacturing process set-up and scale-up.
Strong communication and presentation skills, particularly with customers and regulatory bodies.
A self-starter applies his/her own initiative in most situations.
Proven ability to manage multiple projects simultaneously.
Please phone Larry on 01-2302400 / firstname.lastname@example.org / www.rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.
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Key words: Manufacturing Engineering, Process Engineer, Engineering, Biomedical, Medical Devices, NPI, NPD, Product development, Roscommon, Galway, Clare, Westmeath, Connaught.