Engineering - Associate, Validation

Engineering - Associate, Validation#26-13799 Kansas City, MO All On-site 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

EEO:

- Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans