Key ResponsibilitiesSupport and improve cleanroom manufacturing processes in line with quality, cost, and delivery goals.Lead and contribute to New Product Introduction (NPI) initiatives from concept to commercialisation.Implement continuous improvement strategies to optimise efficiency, reduce waste, and enhance process reliability.Prepare and execute validation protocols (IQ/OQ/PQ) and support equipment qualification activities.Develop and maintain process documentation including work instructions, FMEAs, and process flow diagrams .Investigate non-conformances and implement CAPAs to ensure product and process compliance.Collaborate cross-functionally with Quality, R&D, and Production teams to meet project timelines.Ensure all activities are compliant with GMP, ISO 13485, and regulatory standards .Candidate RequirementsDegree in Engineering, Manufacturing, Biomedical, Mechanical, or a related discipline.Minimum 2 years' experience in a regulated manufacturing environment, ideally medical devices.Strong knowledge of GMP, process validation, and manufacturing best practices.Demonstrated experience in problem-solving tools (e.g., 5 Whys, Fishbone, FMEA).Excellent communication and cross-functional collaboration skills .