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CSV Engineer

Katalyst Healthcares & Life Sciences -
Raritan, NJ

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Job Details

Contract

Qualifications

Quality control corrective actions
Data integrity assurance
Feature validation testing
Industrial automation
Database systems
Quality records maintenance
Human-machine interface (HMI) systems
Defect resolution root cause analysis
Test Case Documentation (Quality assurance practices)
Preventive action implementation
Data Retention (Data management)
Production deviation management
Laboratory information management systems
Good documentation practices (GDP)
Corrective and preventive actions (CAPA)
GMP
Quality reports
SQL
Manufacturing facility experience
Production validation processes
Change management for system development
Quality risk management
Quality control documentation
Compliance documentation
Data access controls implementation
Data backup
Internal compliance assessments
Supervisory control and data acquisition (SCADA)
Access control management
Engineering functional testing

Full Job Description

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.
Apply a risk-based approach (GxP impact, patient/product risk, data integrity) to define validation scope and testing depth.
Author 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.
Able to work in Manufacturing and Laboratory GMP/GLP facilities at client site.

Quick Apply

Refine Your Search

i e engineer jobs

CSV Engineer

Engineer I (II)

Engineer I-III

Engineer I

MEMS Engineer II

I & E Engineer

Application Engineer

Control Systems Engineer I

Mechanical Engineer I/II

Staff - Signal Integrity Engineer

Mechanical Engineer

Field Service Engineer

Masonry Estimator (3yrs Exp Req)

Systems Engineer

Maintenance Technician - Rotating DuPont Schedule

Senior Marine Electronics Exterior Communication Engineer

Product Applications Engineer (Control Systems)

Principal Engineer, Power Design

Applications Engineer-Food Applications

Field Service Engineer

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