Main Duties & Responsibilities Ensure computer system validation activities completed are compliant with internal procedures and external regulations and standards. Assist in development of validation strategy and validation plan for computer system validations. Assist in resolution of deviations/ exceptions during qualification activities Assist with change control activities in accordance with site procedures Support the QA Validation team leader in driving improvements within the Validation and Change Control processes to streamline the validation activities associated with system changes and new technology development. Participate in cross-functional teams as required. Principle Accountabilities Computer System Validation input for equipment and computer systems including new technologies. Adherence to site validation procedures and regulatory requirements. Adherence to site procedures. Experience and Education Experience Essential Hons. Degree Quality/ Manufacturing / Engineering / Science or related field Minimum 2 years of related industry experience. Minimum of 3 years' experience with automated system development or operation. Strong knowledge of Quality systems (FDA/ISO) within a regulated environment including 21CFR Part 11. Strong knowledge of system development life cycle and GAMP. Validation experience with automated manufacturing system. Desirable In depth knowledge of 21 CFR 820, 21 CFR 11, ISO 13485 and European regulations associated with the medical device industry High understanding of GMP, Compliance, Validation practices including the system development life cycle and regulatory expectations.