Process Development Engineer
Lotusworks
Galway
About Us. A valued and trusted partner to the world’s leading companies. We are committed to service excellence through our talented people who are empowered to be innovative and best in class. Location. Galway is a City and County which caters for everyone. Even though Galway City is one of the fastest growing cities it still retains that friendly feeling! With Culture, Dining, Socialising, Sport, Leisure and a state of the art University and College, there is a fantastic lifestyle on offer if you are relocating. If you already live in Galway, well then lucky you! Join us and work with us to deliver the excellent service we are renowned for with our clients. Be part of something great. Job Purpose. Working with the LotusWorks team as Process Development Engineer you will join the New Product Development organization. You will work closely with R&D and Manufacturing on the development of robust, capable, cost effective & safe manufacturing processes, equipment, materials and products. You will support efficient and effective transfer of new products & processes into commercial production. Key Responsibilities. Previous new product development and/or manufacturing experience in medical / pharmaceutical industries a distinct advantage; in particular 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. Demonstrates strong technical expertise on process/product technologies to support selection, design, optimisation, validation and troubleshooting of, and can mentor engineers and technicians in problem resolution on, those technologies. Continuous improvement focus, demonstrating strong knowledge of Six Sigma methodologies and applies these tools in the characterization, optimization and troubleshooting of process equipment and technology performance. Demonstrates strong knowledge and application of Lean methodologies, and process improvement tools in identification and elimination of "waste" process stepsand 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. Leads the development and execution of experimentation and testing to enable characterisation, optimization and troubleshooting of key processes and equipment and summarises, analyses and draws conclusions from test results leading to effective technical resolution. 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. Co-ordinates execution and documentation of validation builds, co-ordinates testing of validation units and the compilation, analysis and reporting of the validation results. Supervision of one or more Technicians, managing their technical development and facilitating their daily and project tasks as required. Demonstrates a primary commitment to patient safety and product quality. Ensuresalldirect reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work. Understandsand complieswith all the regulations governing the quality systems. Travel to other sites / vendors as part of Technology development & transfer activities. Requirements: Honours Degree - HETAC Level 8. Minimum of 3 years post graduate experience. Benefits. Life Assurance. Pension Contribution. Training & Educational Assistance (Engineers Ireland CPD Members. Healthcare Contribution. Annual GP Check-Up. Extra Annual Leave. Healthcare Screening. Not ready to apply, or have some questions? Call our Talent Specialist’s on 07191-69783 or Email jobs@lotusworks.com and we will be happy to help! LotusWorks is proud to be listed in the Best workplaces 2017. Empowering talent we care about for over 27 years. LotusWorks is an Equal Opportunity Employer. This job originally appeared on RecruitIreland.com.
2439 days ago