What are the responsibilities and job description for the CSV Engineer position at i-Pharm GxP?
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