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Plans, develops, and implements documentation, procedures, and trainings necessary for the engineering team. Actively participate in the Validation Life Cycle of regulated projects by reviewing validation documentation, participating in application requirements definition, risk assessments, traceability matrix, validation protocol development, validation testing and deviation management. Generation of validation plans, User Requirement Specifications (URS), Functional Requirement Specifications (FRS), System Design Specifications (SDS), traceability matrix, as well as development and execution of validation protocols (FAT/SAT/IQ/OQ/PQ), and completion reports. Provide statistical analysis of the date to support the reports. Develop statistically based sampling plans for in-process and final testing and inspections, and validations. Review and approve validations and completion reports for new and existing computer and automation systems. Troubleshooting computer and automation systems that do not perform as intended during validation runs. Recommend process/quality improvements as part of validation runs.

4-6 years of experience. Bachelor's degree is required.

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Why Kelly ® Engineering?

Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world’s most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we’re here to guide you to the next step in your engineering career.

About Kelly

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Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.