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CSV Engineer

Raritan, NJ, US • Posted 2 days ago • Updated 10 hours ago

Full Time

On-site

Fitment

Dice Job Match Score™

👾 Reticulating splines...

Job Details

Skills

Collaboration
Requirements Traceability
Test Strategy
Test Execution
Management
Reporting
Risk Assessment
Traceability Matrix
Test Scripts
Regulatory Compliance
Enterprise Resource Planning
Access Control
Recovery
Root Cause Analysis
Corrective And Preventive Action
Hardening
Backup Administration
Identity Management
Network
Interfaces
MES
LIMS
Data Flow
Siemens
Allen-Bradley
Wonderware
OSIsoft
OPC
SQL
Programmable Logic Controller
SCADA
HMI
Documentation
Auditing
Change Control
Risk Management
GxP
Computerized System Validation
Data Integrity
Testing
Manufacturing
GMP
GLP

Summary

Job Summary:

Shop Floor CSV/CSA Lead/Engineer responsible for leading and executing validation deliverables across the lifecycle in regulated manufacturing and laboratory GMP/GLP environments.
The role includes automation/controls validation, risk-based validation activities, audit readiness, data integrity compliance, and coordination with IT/OT teams for validated systems.

Roles & Responsibilities:

Lead and execute validation deliverables including risk assessment, validation planning, requirements traceability, test strategy, test execution, deviation management, and final reporting/release.
pply a risk-based approach (GxP impact, patient/product risk, data integrity) to define validation scope and testing depth.
uthor and review validation documentation including Compliance Plan/Test Protocols, Risk Assessments, Requirements and Traceability Matrix (RTM), test scripts, test summaries, and compliance reports.
Validate PLC logic changes including configuration, recipes, alarms, interlocks, and permissives.
Validate SCADA/HMI functions including screens, alarms, trends, historian interfaces, user roles, and electronic records.
Support MES/PLC/SCADA/ERP interface validation activities.
Ensure data integrity controls for automation data including audit trails, access controls, backups/restore, record retention, time synchronization, and change control.
Support audits and inspections by providing validation documentation and evidence of control effectiveness.
Review and approve vendor documentation including FAT/SAT and integrate into validation packages.
Participate in deviation investigations, root cause analysis, and CAPA activities related to validated systems.
Coordinate with IT/OT teams on system hardening, patching strategies, backups, access management, and network segmentation impacts to validated systems.
Validate interfaces including PLC-SCADA, historian, MES, and LIMS controlled data flows.
Work with technologies including Siemens, Rockwell/Allen-Bradley, Schneider, ABB PLCs, Ignition, Wonderware/AVEVA, FactoryTalk View, WinCC, iFIX, OSIsoft PI, OPC/OPC UA, and SQL-based integrations.

Experience:

Experience in automation/controls and validation/qualification within regulated or quality-managed environments.
Hands-on understanding of PLC/SCADA architectures, control strategies, alarms, and HMI design concepts.
Strong documentation skills with ability to produce audit-ready validation evidence.
Working knowledge of change control, deviation handling, and risk management.
Experience with GxP environments and computerized system validation (CSV) / computer software assurance (CSA) approaches.
Familiarity with electronic records/e-signatures expectations and data integrity principles.
Experience with commissioning and FAT/SAT testing.
ble to work in Manufacturing and Laboratory GMP/GLP facilities at client site.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: 5a872b785251d7f46d32482f6174c9f4
Posted 2 days ago

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