Sr Engineer Software Validation

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. 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. Support division facilities on-site when needed. Bachelor's degree in Engineering, Quality, Business, or Computer Science. Work Experience: At least 5 years of experience in Manufacturing, Quality or Engineering. Direct experience operating in a medical device QMS environment, including FDA 21 CFR Part 820, ISO 13485, ISO 14971, General Principals of Software Validation, Electronic Records/Signatures. Experience applying knowledge of standard concepts, practices, and procedures within software engineering. Experience with project management (for example: planning, organizing, and managing resources to bring about the successful completion of specific project goals and objectives). Experience working in an AS400 environment. Position requires travel up to 25% of the time for business purposes (within state and out of state). Work Experience:

• Experience in Manufacturing, Quality or Engineering including 4 major validation subjects (e.g. Computer, Equipment, Cleaning, Process, etc.).
• GAMP Good Practice Guide: IT Infrastructure Control and Compliance (GAMP 5)
• ISO / Customer / Regulator Audits
• FDA Product and Establishment Registration
• Quality Management System / Medical device environment experience.

Proficient in MS Word, Project, Excel. Continuous improvement and Kanban related project experience Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold. Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.