CSV Engineer

Responsibilities Provide CSV support for the design, configuration, and validation of Electronic Batch Records within the site Manufacturing Execution System.Develop and execute validation documentation including validation plans, risk assessments, test protocols (IQ/OQ/PQ), traceability matrices, and summary reports.Lead validation testing activities for electronic batch record workflows and associated manufacturing equipment integrations.Ensure compliance with GxP, data integrity, and computer system validation requirements.Partner with MES engineers, automation engineers, manufacturing operations, and quality assurance teams to ensure validated system deployment.Support user acceptance testing (UAT) and functional verification of batch record processes within the MES platformExperience Proven experience delivering Computer Systems Validation in pharmaceutical or biotech manufacturing environments.Strong hands-on experience with Manufacturing Execution Systems supporting electronic batch records.Demonstrated experience validating EBR workflows including system configuration testing and batch record execution.Experience developing and executing CSV documentation in alignment with FDA and GxP expectations.Familiarity with equipment integration within MES environments (process equipment, automation systems, or data historians).Experience with pharmaceutical MES platforms such as Syncade, PharmaSuite, or similar batch execution systemsExperience supporting biologics or sterile manufacturing operations.Knowledge of data integrity expectations and electronic records compliance