CSV Engineer

We are seeking a CSV Engineer to lead validation workstreams for automated control systems. In this role, you will ensure the Siemens PCS7 platforms remain compliant, secure, and optimized while upholding global data integrity standards.

This is a 12 month hourly rate contract position.

Key Responsibilities:

• Lead end-to-end validation for Siemens PCS7 systems. This includes authoring and executing Validation Plans, URS, FS, DS, and IQ/OQ/PQ protocols.
• Act as the SME for ALCOA+ principles, managing audit trails, user access, and data storage compliance.
• Conduct System Impact and Quality Risk Assessments to safeguard product quality and patient safety.
• Manage technical change controls, lead deviation investigations, and oversee FAT/SAT for new PCS7-based equipment skids.

Requirements:

• Bachelor's Degree in Engineering, Computer Science, or a related Life Science discipline.
• 3-5+ years of CSV experience within a Pharma / Med-Device environment.
• Hands-on experience validating Siemens SIMATIC PCS7, including WinCC, Step 7, and Batch operations.
• Strong command of GAMP 5, 21 CFR Part 11, and EU Annex 11.