Engineering Validation Associate

Evaluate, review, and approve validation master plans, protocols, and reports, ensuring compliance with regulatory requirements and company policies. Troubleshoot validation problems for equipment and performance processes, conducting statistical analysis of testing results to address process anomalies. Write, review, and approve validation process documents and technical reports related to equipment, products, and processes. Contribute to project tasks and milestones, organizing work to meet deadlines and applying basic team effectiveness skills within the immediate Work Team. Make decisions within limited options to resolve basic problems, working under the supervisor's direction and seeking guidance from colleagues. Ensure work is regularly reviewed for technical judgment, completeness, and accuracy, exercising judgment with reliance on the supervisor. Determine the process capability of new equipment through the execution of approved protocols, incorporating defined parameters into operating procedures and batch records. Assist with the development of validation protocols, manage regulatory queries and responses, and participate in deviation investigations to identify root causes and define corrective and preventative actions. Adhere to all company and Good Manufacturing Practices (cGMP) procedures, safety regulations, and participate in the development of validation programs to stay current with cGMPs and industry standards. Work effectively as a member of the Engineering Validation team, collaborating with Business Area Training Leads, Coordinators, and SMEs to support cGMP and site training initiatives, reporting to the Validation Section Manager and summarizing data into concise reports for review and approval.