Job Title

Job Title: Computer System Validation Engineer (Offshore - Midlevel) Reports To: Senior Manager, Computer System Validation or Director of IT GxP Systems Employment Type: 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 Computer System Validation Engineer 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. The position will be a point of contact managing internal resources and represent Celito Tech with both internal and external stakeholders. Responsibilities and Duties Work collaboratively with project’s CSV lead and accomplish task with minimum guidance Work collaboratively across functions with Celito or client Quality, and IT or software vendor to execute CSV activities utilizing a risk-based approach 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 and 3+ years of related experience; or equivalent combination of education/training and experience Additionally, 3+ years of direct validation responsibilities in Computer Systems Validation experience Experience in performing validation of cloud-based Computer solutions and infrastructure qualification A strong knowledge of procedures and best practices related to FDA Regulations, 21 CFR Part 11, Computer System Validation, GAMP 5, GxP (GLP, GCP, GMP, and GVP) practices Ability to communicate regulations and requirements to teams and clients Experience with validation of Quality Management Systems (QMS) such as Veeva Vault, ZenQMS, or MasterControl, including Electronic Document Management Systems (eDMS), Clinical Systems (veeva eTMF, Veeva RIM), DocuSign Part 11, SharePoint, Learning Management Systems (LMS), and/or Laboratory Information Management Systems (LIMS) is required Knowledge of QMS processes including: Controlled Document Management, Learning Management (Training), Deviation/Event Investigation, Corrective and Preventive Action (CAPA), Change Control Management, and Audits and Inspections Consulting for multiple companies is preferred 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