Senior Validation Engineer - Biotech 8-12 month contract intitially - $80-$100 per hour DOE The Validation Engineer is responsible for providing Validation and Quality Engineering Support to new and existing Pharmaceutical Manufacturing Operations. The selected candidate will interface with Management personnel in Engineering, Manufacturing, Regulatory Affairs, and other technical disciplines to represent QA/Validation in project teams, with the objective to assure that project quality objectives are met. This person will design and execute Validation Plans and Programs for new and improved pharmaceutical manufacturing processes and products as well as design and implement Quality Control and Quality Assurance systems for new and existing pharmaceutical manufacturing processes and products. * Provide leadership and technical decision making for Management and high level technical personnel regarding cGMP compliance, regulatory issues, validation strategy, and quality systems for projects and/or strategic activities. * Formulate recommendations for disposition or other actions related to product nonconformance and field performance issues. * Assist in the supervision of associate validation staff including specialized contract personnel/vendors in the performance of validation services. * Represent the company in contacts with regulatory agencies, including interface with FDA investigators.