Computer System Validation (CSV) only W2 (NO CTC OR C2H)

CSV/CSA Lead/Engineer

Raritan, NJ onsite

6 MOnths

Job Description - Shop floor CSV/CSA Lead/Engineer
• 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/HMI (human-machine interface) functions: screens, alarms, trends, historian interfaces, user roles, and electronic records (as applicable).
• MES/PLC/SCADA/ERP interface experience is plus.
• Ensure data integrity controls for automation data (e.g., time sync, audit trails, access controls, backups/restore, record retention, change control).
Quality, compliance, and governance
• Support audits/inspections by providing documentation and clear evidence of control effectiveness.
• Ensure changes follow change control and that testing evidence supports release decisions.
• Review/approve vendor documentation (FAT/SAT—factory/site acceptance testing) and integrate into the validation package where appropriate.
• Participate in deviation investigations, root cause analysis, and CAPA (corrective and preventive action) related to validated systems.
IT/OT and interface
• Coordinate with IT/OT teams on system hardening, patching strategy, backups, access management, and network segmentation impacts to validated state.
• Validate interfaces (e.g., PLC–SCADA, historian, MES, LIMS) and confirm controlled data flows.
Typical systems & technologies
• PLCs: Siemens, Rockwell/Allen-Bradley, Schneider, ABB (varies by site)
• SCADA/HMI: Ignition, Wonderware/AVEVA, FactoryTalk View, WinCC, iFIX (varies)
• Historian/Batch/Interfaces: OSIsoft PI (or equivalent), batch/reporting tools, OPC/OPC UA, SQL-based integrations
• Validation toolsets: requirements/traceability repositories, electronic validation platforms (site-dependent)
Required qualifications
• Experience in automation/controls and validation/qualification for regulated or quality-managed environments.
• Hands-on understanding of PLC/SCADA architectures, control strategies, alarms, and HMI design concepts.
• Strong documentation skills and 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 (when applicable) and data integrity principles.
• Experience with commissioning & FAT/SAT testing.
• Able to work in Manufacturing and Laboratory GMP//GLP facility at client site

Regards,

Vikram Raj

I

Symphony Corporation | Madison, WI | A SEI-CMMI Level 4 Company

We synchronize business, technology