Validation Associate

Pay range: 20-26/hr •depending on experience This position serves as a validation representative for laboratory validation activicties, 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 assigned III.

Position Requirements Education 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