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Position Overview
We are looking for an experienced CSV Engineer to support the validation and lifecycle management of computerized systems in GMP-regulated manufacturing environments. The role bridges automation, IT, and quality compliance, ensuring validated systems maintain data integrity, regulatory compliance, and operational excellence.
Key Responsibilities
Position Overview
We are looking for an experienced CSV Engineer to support the validation and lifecycle management of computerized systems in GMP-regulated manufacturing environments. The role bridges automation, IT, and quality compliance, ensuring validated systems maintain data integrity, regulatory compliance, and operational excellence.
Key Responsibilities
- Lead and execute Computer System Validation (CSV) activities in line with GxP, FDA, and EU GMP requirements
- Develop, review, and manage validation documentation, including URS, FS, DS, IQ/OQ/PQ protocols, risk assessments, and traceability matrices
- Support commissioning and qualification of Building Management Systems (BMS) and Environmental Management Systems (EMS)
- Validate and maintain DeltaV hardware, applications, and software environments
- Oversee MES validation for Production and Quality modules
- Integrate and validate industrial data platforms such as HighByte and Kepware
- Support automation and scheduling platforms (Dynamic Equipment Scheduler, Green Button Go)
- Ensure validated state compliance for asset management and change control platforms (OctoPlant)
- Contribute to validation for advanced manufacturing systems like Cellular Origins Constellation
- Collaborate cross-functionally with QA, IT, Engineering, and Operations teams
- Bachelor s degree in Engineering, Computer Science, or related field
- Proven CSV experience in pharmaceutical, biotech, or advanced manufacturing environments
- Strong knowledge of GMP, GAMP 5, 21 CFR Part 11, and EU Annex 11
- Hands-on experience with DeltaV systems (hardware, application, software)
- Experience validating MES Production and Quality modules
- Familiarity with industrial data integration, OPC connectivity, and automation scheduling tools
- Excellent documentation, risk assessment, and stakeholder communication skills
- Experience in cell therapy or highly automated manufacturing environments
- Strong understanding of data integrity principles and audit readiness
- Ability to manage multiple validation projects simultaneously