DeltaV Process-CSV/DCS Engineer
The DeltaV Process-CSV/DCS Engineer supports the design configuration validation and lifecycle management of Emerson DeltaV DCS in a GxP-regulated life science manufacturing environment.
The role ensures process control systems are validated per GAMP 5 21 CFR Part 11 and EU Annex 11 maintaining data integrity reliable batch execution and inspection-ready compliance.
Experience : 4 - 8 years experience ideally in GMP environment
Technical Skills: GMP Essential CSV Emerson DeltaV otherDCS System
Responsibilities :
- Configure modify and maintain DeltaV control modules phases recipes alarms and graphics in line with ISA-88 batch standards
- Prepare and execute CSV deliverables per GAMP 5 including URS FS/DS risk assessments IQ/OQ/PQ protocols and traceability matrices
- Ensure compliance with 21 CFR Part 11 EU Annex 11 and data integrity (ALCOA+) requirements including security audit trails and electronic signatures
- Support integration of DeltaV with Syncade or PAS-X MES historians OPC servers and PLC/SCADA-based equipment Provide L2/L3 support troubleshoot control system issues and perform root cause analysis to minimize process downtime
- Author and manage change controls deviations CAPAs and impact assessments to maintain a validated state Manage user accounts roles backups restores version control and periodic reviews in line with SOPs Plan and support DeltaV upgrades patches migrations and lifecycle activities
- Collaborate with Manufacturing Automation QA IT and Process Engineering to support new projects tech transfers and equipment qualification Maintain SOPs and system documentation and support audits regulatory inspections and continuous improvement initiatives
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