CSV Engineer

Company Overview

We are a process automation service provider for the life science industry, delivering automation solutions and manpower resources for daily operations and projects.

Job Summary

You will lead computer system validation (CSV) for Windows OS upgrades and administer WinCC/Siemens PLC systems, ensuring compliance, risk management, and system integrity within regulated environments.

Responsibilities

• Classify IT assets and evaluate GxP impact for Windows OS obsolescence upgrades
• Lead validation planning, system risk assessments, and execution of IQ/OQ protocols, including PQ when necessary
• Manage traceability, requirements, backup and restore processes, and generate compliance reports
• Perform risk-based testing tailored to images, instrument PCs, and servers to optimize validation efforts
• Maintain change control documentation and audit-ready evidence in collaboration with QA and project management
• Administer WinCC/SIMATIC systems by managing user access, controlling configuration changes, and verifying backups
• Provide technical support for fault diagnosis related to WinCC/Siemens PLC systems without full-time programming responsibilities
• Draft validation protocols that meet QA approval standards

Required competencies and certifications

• Expertise in CSV and Commissioning & Qualification (C&Q) following GAMP 5 guidelines, including IQ/OQ and change control
• Qualification in Windows OS, infrastructure, or workstation management within a regulated site
• Hands-on experience administering WinCC and/or SIMATIC systems for access control, configuration, and backup

Preferred competencies and qualifications

• Experience with Windows 11 upgrades
• Familiarity with laboratory instrument PCs
• Knowledge of Part 11 / Annex 11 regulatory requirements
• Exposure to TIA Portal and Step 7 software

Role : CSV Engineer, Windows 10 / 11 + Siemens WinCC / PLC Seniority 4–8 years. Primary CSV for Win10 to Win11 and later Server 2016. Secondary WinCC/ Siemens PLC admin: access, config, backup.

Purpose:

CSV owner for the domain-connected OS obsolescence programme. Also administer WinCC / Siemens PLC access, configuration and backups.

Duties

• Classify assets and assess GxP impact of the OS change.
• Own VP, system risk assessments, IQ/OQ (PQ if needed), traceability, RERS, Backup and restore and reports.
• Risk-based testing: image vs instrument PC vs server. Not full OQ on every box.
• Keep change control and evidenceaudit-ready with QA and the PM.
• WinCC / SIMATIC: user access, controlledconfig changes, verified backups.
• Support fault-finding. Admin/config role,not full-time PLC programmer.

Must have

• CSV / C&Q: GAMP 5, IQ/OQ, change control.
• One Windows OS, infrastructure or workstation qualification in a regulated site.
• Hands-on WinCC and/or SIMATIC admin: access, config, backup.
• Can write a protocol QA will sign.

Nice to have

• Win11. Lab instrument PCs. Part 11 / Annex11. TIA Portal / Step 7.