Role Summary:
* Our client is seeking a highly motivated R&D Engineer to join their Research and Development Team based at their busy pharmaceutical facility in Co. Waterford.
* This role involves supporting the development and optimisation of new and existing products, processes, and technologies within the client's advanced ophthalmic portfolio.
* The successful candidate will contribute to innovative projects while ensuring compliance with industry standards and collaborating with cross-functional teams.
Core Duties and Responsibilities:
* Lead & participate in product + process development activities, writing protocols/reports, data gathering & analysis, focusing in particular on development of optimized solutions for new and existing materials, manufacturing processes & technologies.
* Design & development of new products + processes, including concept development, high-level design feasibility, prototype development, detailed designs, test method development, process capability finalization, design verification/validation, and facilitate introduction & transfer to live manufacturing.
* Act as project team member or individual contributor as required, managing deliverables, priorities, schedule and cost, and providing regular updates to meet team/business needs.
* Investigate and analyse data, providing recommendations on trends, correlations, response variables, DOEs etc to better understand process and/or equipment interdependencies, and identifying solutions to complex technical challenges & automation requirements.
* Be a subject matter expert associated with products + processes in development.
* Facilitate & lead generation of product + process specifications, DOEs, and process capability analyses.
* Interface with local and global internal cross functional teams.
* Overseeing & selecting vendors, materials & manufacturing methods of new & existing equipment to support new product/process validations.
* Create new WI and SOPs for operation of new equipment, set up & qualify/validate equipment as required to support development activity.
* Provide process optimization for, and support, existing manufacturing processes, quality improvements and cost reductions initiatives.
* Ensure product quality and all tasks are in accordance with requirements per established SOPs, GMPs, Divisional Specifications, and EHS standards.
Minimum Qualifications and Experience:
* Minimum of Degree in Science, Engineering or similar discipline.
* Experience: 3+ years in Engineering, Process Development, and/or Quality Engineering setting. Hands-on experience and technical expertise in development environment a must.
* Excellent Communication, Organization, Technical Reports, and Presentation skills a must.
* Must be able to develop working relationships with various internal core competencies and work as a team member. Ability to influence others without direct authority.
* Computer Literacy with skills in MS Excel/Word/Access, plus MiniTab, JMP (or equivalent), with expertise in Statistical Analysis (DOE, SPC) in development or manufacturing setting.
* Ability to identify product requirements from international standards & regulatory directives.
* IS0-9000, GMP, medical device manufacturing experience a plus. Experience with high volume and/or high precision manufacturing a plus.