Description. In this role the candidate will be part of the engineering team responsible for equipment and process work associated with new inhalation product introduction. The key responsibility of the process engineer will be to lead the definition and delivery of manufacturing processes for new and existing products. The successful candidate will be involved in all aspects of product supply from design right through to equipment validations and product commercialisation. Responsibilities & Duties. Manage the Engineering activities within assigned projects to deliver manufacturing processes for both new and existing products. Detailed review and revision of proposed design(s) with product development team to meet design objectives. Collaborate in new product / process design to ensure ease of manufacturability is an integral part of the product / process design. Development of User Requirements Specification for all required manufacturing equipment. Planning and execution of equipment validations. Development and management of project schedules for new processes/equipment. Development of capital expenditure plans for manufacturing equipment. Engagement of other Operations functions in critical decisions and developments. Provide technical support to the Manufacturing or Packaging areas. Lead investigations to root cause any process issues which occur and to provide and implement suitable CAPAs to completion as per agreed timelines. Lead and support improvement projects in Manufacturing. Troubleshoot technical issues, investigate and write deviations, working closely with all departments to close out immediate and longer term CAPAs as per agreed timelines. Raise and critically review Change Controls and ultimately close as per agreed timelines. Critically review and approve BMRs and procedures for appropriate and suitable content such that errors are minimised and details are compliant. Write, review and approve Investigation reports, study protocols and reports for process improvement. Document and seek approval for New product and component introduction. Experience in Metered dose inhalation would be an advantage. Qualifications : Primary Degree in Engineering discipline, preferably Mechanical / Manufacturing Engineering or science. Minimum of 5-8 years’ post qualification experience in manufacturing environment. Proven track record in production equipment development and execution preferably within a regulated environment, Medical device or pharma preferred. Good knowledge of GMP/HPRA/FDA regulatory requirements and current Health and Safety Regulations legislation. Good Presenting and Training Skills. Good Technical writing skills. Excellent communications and decision-making skills. Proven ability to work well as part of a team & on own with minimum supervision. ** You must have the right to work in Ireland for these roles ** If you have the above skills & experience and you are looking for the next step in your career, please contact Sean.Fahy@cpl.ie.
22 days ago