Associate, Validation

**Job Title: Associate, Validation Job Location: Kansas City, MO Job Duration: 6 Month on W2 Shift:- Mon- Fri 8AM - 5PM** Job Description 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 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