Job Description
Raritan, NJ onsite
Shop floor CSV/CSA Lead/Engineer
Only on W2
No C2C
USC/ GC/ TN-Visa Only
• Lead and execute validation deliverables across the lifecycle: risk assessment, validation planning, requirements traceability, test strategy, test execution, deviation management, and final reporting/release.
• Apply a risk-based approach (e.g., GxP impact, patient/product risk, data integrity) to define validation scope and testing depth.
• Author/review validation documentation such as:
o Compliance Plan / Test Protocol (as applicable)
o Risk Assessments (e.g., system impact, functional risk)
o Requirements and Traceability Matrix (RTM)
o Test scripts, test summaries, and compliance reports
Automation/controls validation
• Validate PLC logic changes (including configuration, recipes, alarms, interlocks, permissives) and verify alignment to approved requirements.
• Validate SCADA/H...
Shop floor CSV/CSA Lead/Engineer
Only on W2
No C2C
USC/ GC/ TN-Visa Only
• Lead and execute validation deliverables across the lifecycle: risk assessment, validation planning, requirements traceability, test strategy, test execution, deviation management, and final reporting/release.
• Apply a risk-based approach (e.g., GxP impact, patient/product risk, data integrity) to define validation scope and testing depth.
• Author/review validation documentation such as:
o Compliance Plan / Test Protocol (as applicable)
o Risk Assessments (e.g., system impact, functional risk)
o Requirements and Traceability Matrix (RTM)
o Test scripts, test summaries, and compliance reports
Automation/controls validation
• Validate PLC logic changes (including configuration, recipes, alarms, interlocks, permissives) and verify alignment to approved requirements.
• Validate SCADA/H...