Sr Engineer Software Validation

Job description

Job Summary Job Description: JOB SUMMARY: Deliver leadership-level role in the development and execution of validation projects, ensuring customer and regulatory requirements are met in a timely and satisfactory manner. MAJOR RESPONSIBILITIES: - Evaluate systems and applications to properly design organized and efficient software, process, automation, cleaning, facility, and utility system related validations. - Ensure scope and complexity of validations are commensurate with risk including the design, development, and implementation of test strategy, plans, scripts, and test procedures to meet requirements. - Coordinate, Execute, and Report on validation plans for custom and off-the shelf software. - Manage multiple, concurrent validation projects, including gathering and understanding customer requirements and effectively communicating project status to keep customer informed and satisfied. - Document validation protocols and reports with professional and technical written communication skills. - Know, support, and conform to Medline policies and relevant governing procedures. - Maintain awareness to industry and regulatory environment, including FDA, GAMP, ISO. - Maintain organi...