1 of 1 21 CFR Part 11 Jobs in County Antrim

Senior Manufacturing System Engineer

Location
Belfast City District, Northern Ireland, United Kingdom
continuous improvement. Develop, maintain and improve manufacturing software systems, electronic records, reporting tools and digital workflows in compliance with GMP, FDA, ISO 13485, 21 CFR Part 11 and applicable regulatory requirements. Lead Computer System Validation (CSV) activities, including the development and execution of Validation Plans, Risk … both internal and external agents. Confident and effective decision maker, with a proven leadership ability to negotiate and influence others. Capable of working as part of a multi-disciplined team in an aggressive, dynamic and results motivated environment. Demonstrable analytical & problem-solving skills, a process improvement orientation ...