Computer Systems Validation Junior Engineer

Job Title : Junior Computer System Validation Engineer (Offshore) Reports To: Senior Manager or Manager Computer System Validation Employment Type: Internship, Followed by Full-time Workplace Type: Remote The Celito Team The Celito Team architects the buildout of simplified, integrated, and compliant technology stacks. With both consulting and products, our expertise can help our customers save time and money as they move from strategic Clinical & Quality management all the way to widespread and profitable commercialization. Job Overview The Junior Resource - Computer System Validation is responsible for execution of GxP Computer System Validation (CSV) activities in accordance with industry standards and regulatory guidance to ensure the systems are appropriately validated prior to release and remains in a compliant state throughout the lifecycle. Responsibilities and Duties Work collaboratively with project’s CSV lead and accomplish task with minimum guidance Authoring, review, and approval of CSV deliverables including but not limited to change controls, system risk assessments, validation plans, user and or functional requirements specification, configuration specifications, IQ/OQ/PQ protocols, traceability matrix, summary reports and applicable SOPs (System Administration and User/Operation) Perform execution to ensure the testing was performed appropriately and the test results are compiled in a timely manner Maintaining the validated state of client supported GxP systems including periodic review and release management Collaborate with offshore resources (in India) and onshore resources which means the candidate must be available until 11am PT US hours Qualifications Bachelor’s degree in life sciences or engineering or pharmacy Knowledge of performing validation of cloud-based Computer solutions and infrastructure qualification is a plus Work on multiple projects at the same time in a fast-paced environment, with limited supervision. Works with various clients, vendors, and team members to ensure project/program goals are met Strong written and oral communication skills, able to translate complex concepts across all levels of the organization Show more Show less