Job Description:
- Develop and implement Computer System Validation (CSV) protocols and procedures in accordance with industry standards for DeltaV.
- Conduct risk assessments and validate computer systems, software, and automated processes to ensure compliance.
- Collaborate with cross-functional teams to gather requirements and define validation strategies.
- Create and execute validation plans, protocols, and reports, ensuring thorough documentation.
Requirements
- Bachelor’s degree in Engineering, Computer Science, or related field.
- Good understanding on deltaV, CSV protocol generation, documentation and coding
- Experience in CSV, specifically with DeltaV systems in the pharmaceutical or biotechnology industry.
- Strong understanding of DeltaV architecture, functionalities, and validation processes.
- Familiarity with electronic documentation systems and regulatory submission processes.