Research & Development Engineer

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.

Please note, we do not require agency assistance with this role.