Associate Validation Engineer

This position serves as a validation representative for laboratory validation activities, including Equipment Qualification and system administration. In addition, this position is expected to provide technical guidance as A SME with respect to validation/process deviations and change controls as pertains to validation impact.II. Essential Functions Generate, execute and summarize validation documentation for process equipment qualification. Lead Validation/Qualification/CSV efforts for equipment purchased or modified (FAT, SAT, OQ, PQ). Coordinate with Quality, technical scientists, and vendors for validation protocols, execution, and final reports Generate, execute and summarize project plans, conduct and peer review change controls, review validation related exceptions events, as well as provide input to site as a SME. Contribute to the development and revision of validation concepts, techniques, and standards to ensure compliance with regulatory requirements. Assist in validation related issue resolutions for all GMP laboratory equipment. Generate and participate in any change control activities as required. Participate in any tasks associated with system implementation or upgrades as required. Lead/support periodic and data integrity reviews. Participate, support, and drive Continuous Improvement initiatives. All other duties as assignedIII. Position RequirementsEducation and Experience: Bachelor’s Degree in Life Sciences, Physical Science, Computer Science or Engineering field with minimum of 3 years relevant experience, OR Master’s degree in related Life Sciences, Physical Science, Computer Science or Engineering field required with a minimum of 1 years relevant experience, OR Doctorate degree in related Life Sciences, Physical Science, Computer Science or Engineering field required with a minimum of 1 years relevant experience.Knowledge/Skills Requirements: Proficient in Microsoft Office products (Word, Excel, etc.) Basic understanding on Minitab or equivalent statistical tool. Experience with IQ, OQ, and PQ activities Experience with GMP and GDP activities. Project management skills