-Responsible for developing, preparing, executing and overseeing the execution of and the revising of validation procedures/protocols to ensure that there is sufficient documentation to support the manufacturing of a product in accordance with appropriate regulatory agency requirements, customer expectations, and internal company standards. -Compiles and analyzes validation data, prepares reports and makes recommendations. -Performs all tasks in accordance to cGMP guidelines and quality standards. -Must be able to work in a team environment and possess team-based problem solving skills. -Must be results focused and oriented toward accomplishment of organizational goals. -Must be able to work flexible hours to include overtime when needed. • Ensure all processes and methods critical to product quality are appropriately qualified, validated and documented • Actively participate during all phases of validation including documents for IQ/OQ • Review engineering drawings • Analyze data and provide recommendations for improvements • Maintain system that tracks validation records • Write, review and approve validation strategies, protocols and reports • Review validation packages for completeness and accuracy, sound rationale, compliance with policies and procedures, and accurate data analysis • Establish priorities and schedule activities to ensure timelines and milestones are met • Some administrative activities may be required as needed

• Bachelor’s Degree in Science, Business • Detail oriented • Proficient in Math • Basic communications and writing skills in English • Ability to interact and work with team members • Ability to communicate knowledge to team • Must have knowledge of current industry expectations of validation requirements for IQ/OQ/PQ/Cleaning/Equipment validations • Ability to handle multiple projects and deliver reports in a timely manner • Ability to determine, present, and defend project requirements and status