About the job
Join our team as a Computer System Validation (CSV) Support Specialist, where you will play a pivotal role in ensuring the integrity and compliance of manufacturing systems. Your expertise will contribute to the lifecycle of Computer System Validation (CSV) through the following responsibilities:
- Create comprehensive Software Development Life Cycle (SDLC) documentation for Manufacturing Equipment, including execution reports for CSV.
- Implement validation protocols as required by clients.
- Deliverables may include User Requirement Specifications (URS), Functional Requirement Assessments (FRA), Design Qualification (DQ), process Failure Mode Effects Analysis (pFMEA), Risk Assessments, Traceability Matrices, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ), Operational Qualification (OQ), Media Fill, Cleaning Validation, and Process Validation.
- Develop CSV System Impact and Risk Assessments as part of the combined Equipment and CSV Validation Plan.
- Create Installation and Operational Qualification protocols and summary reports.
- Review and incorporate test scripts for CSV into Installation and Operational Qualification processes.

