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
Required Qualifications
- 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
Preferred Qualifications
- 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