Validation Engineer

Job Summary This is a remote role but will need to be based in the Chicagoland area as there will be requirements to come on site on an as needed basis. 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 Responsibilities: Evaluate systems and applications to properly design organized and efficient software, process, automation, spreadsheet, AI/Bot vali

Job Summary: Lab Equipment Validation Engineer responsible for leading validation activities for laboratory equipment supporting infusion system testing in a regulated medical device environment, ensuring compliance with FDA regulations, ISO standards, and quality system requirements. Roles & Responsibilities: Lead validation efforts for laboratory equipment supporting infusion system testing (e.g., Infuscale, altitude chambers, environmental chambers, flow measurement instruments, and related t

Key Responsibilities Lead validation efforts for laboratory equipment supporting infusion system testing (e.g., Infuscale, altitude chambers, environmental chambers, flow measurement instruments, and related test systems).Develop and execute validation protocols, test plans, and reports in alignment with FDA 21 CFR Part 820, Part 11, ISO 13485, and equipment validation best practices.Partner with R&D, Quality, and Systems Engineering teams to define equipment validation requirements and riskbase

Job Summary Responsible for the validation of facility utilities, and equipment processes for cGMP products such as pharmaceuticals, medical devices, and cosmetic products to adhere to 21 CFR 211/210, 21 CFR 820, and other applicable regulatory requirements. Assist in authoring and executing protocols to demonstrate that manufacturing processes are executed with consistent quality and results within a controlled environment. Responsible for managing and or performing revalidation, engineering s