We are seeking a highly skilled CSV Engineer to lead the delivery of Process Control System (PCS) software and validation projects. This role focuses on the design, configuration, and computerized system validation (CSV) of DeltaV DCS and PLC systems to ensure compliance with GxP and 21 CFR Part 11 regulations.
Key Responsibilities (Mapped to SOL Duties):
Software Design & Analysis: Analyze user requirements to design and develop software solutions for DeltaV (V15), including Control Modules, Equipment Modules, and ISA-88 Batch recipes.
System Validation (CSV): Lead and execute Computerized System Validation (CSV) protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Software Installation & Operational Qualification (SIOQ).
Documentation: Author and review critical technical software documentation: Functional Specifications (FS), Design Specifications (DS), and System Architecture diagrams.
Digital Validation Tools: Utilize digital validation platforms (e.g., Kneat, ValGenesis) to manage paperless validation lifecycles and ensure data integrity.
Infrastructure & Security: Configure and maintain virtualized environments (Hyper-V, VMware) and HCI (Hyper-Converged Infrastructure) for DCS software deployment, including domain controllers and cybersecurity hotfixes.
Testing & Integration: Manage complex software interfaces between DCS, PLC, and Historian systems; perform loop checks and software shakedowns to ensure system interoperability.
