Sr Engineer Software Validation

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. Job Description 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. 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 organizational excellence, including document control, quality records, detail, and thoroughness. Evaluate ways to streamline and improve efficiencies in software validation and associated processes. Provide team support in all validation initiatives as requested. Support division facilities on-site when needed. MINIMUM JOB REQUIREMENTS: Education: Bachelor’s degree in Engineering, Quality, Business, or Computer Science. Wo