DeltaV Computer System Validation (CSV) Engineer - #1167162
HTC Global Services
Execute DeltaV CSV lifecycle including IQ, OQ, PQ, risk assessments, traceability, and validation reporting.
Validate DeltaV hardware, controllers, I/O systems, servers, and infrastructure.
Validate DeltaV software including Control Modules, Equipment Modules, Unit Modules, batch applications, alarms, graphics, and security.
Support FAT, SAT, commissioning, qualification, and system handover.
Ensure data integrity, audit trails, electronic signatures, backup/restore, and security compliance.
Manage deviations, change controls, and validation documentation.
Collaborate with Automation, CQV, Quality, IT/OT, and Manufacturing teams.
Bachelor's Degree in Engineering, Automation, Computer Science, Pharmaceutical Technology, or related discipline.
Minimum 5 years of DeltaV CSV experience in pharmaceutical, biotechnology, or other GxP-regulated industries.
Strong experience with Emerson DeltaV validation and qualification.
Good knowledge of GAMP 5, FDA 21 CFR Part 11, EU Annex 11, and GMP data integrity requirements.
Strong documentation, testing, and stakeholder management skills.
Preferred
Experience with Siemens SIMATIC, WinCC, or other PLC/SCADA platforms.
Experience with Kneat or other electronic validation systems.
Exposure to OT cybersecurity, virtual infrastructure, or system integration.
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