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 platform Experience • 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 systems • Experience supporting biologics or sterile manufacturing operations. • Knowledge of data integrity expectations and electronic records compliance