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Job Location - Singapore
Designation - CSV Engineer
Job Role - Permanent
Min Exp - 4-5 Years
Notice - Immediate or 30 Days
Pharma background along with basic info/knowledge on DeltaV systems is mandatory
Perform post-execution review of qualification protocol via verification of evidence (PHV/BHV, etc) to ensure commands/logics are tested for positive and negative scenarios
Review test event and able to assess the change impact to its reference's library class/ upper layer objects
Drafting of qualification protocol due to additional changes
Job ID: 149843431
Skills:
21 Cfr Part 11, GAMP 5, Thermal mapping validation, Configuration specification design review, DeltaV programming
Skills:
Functional Specification, User Requirement Specification, Siemens PCS7, GMP compliance, Risk Assessment, CFR Part 11 assessment, Computer Validation Strategy, Reports Study Protocols, IQ OQ PQ CPV, Automation System Life cycle documentation, deltav, ANSI ISA-88, Validation protocols, Requirement Traceability Matrix, GAMP5
Skills:
validation activities, validation documentation, risk assessments, CSV strategies, DeltaV systems, impact analyses, troubleshooting CSV-related issues
Skills:
21 Cfr Part 11, Emerson DeltaV hardware, GxP standards
Skills:
Csv, 21 Cfr Part 11, System Integration Testing, data integrity, IQ OQ PQ protocols, parameter configuration, module coding, Phase-level logic, deltav, batch architecture, Troubleshooting, S88 standards, GAMP5
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