Automation CSV Engineer
Siva KalyanUnited StatesMIDPosted 10d ago
Emerson DeltaVAVEVAOSIsoft PI SystemSCADAPLCHMIbatch applicationsIQ/OQ/PQGMP21 CFR Part 11GAMP 5validation documentationrisk assessmentschange controldeviationsCAPA
About the Role
We are seeking an experienced Automation CSV Engineer to support validation, compliance, qualification, and lifecycle management of GMP automation and computerized systems in a regulated manufacturing environment.
Key Responsibilities
• Develop and support validation strategies for GMP automation systems
• Prepare, review, and execute validation protocols, test scripts, and qualification documentation
• Support FAT/SAT, IQ/OQ/PQ, regression testing, and automation functional testing
• Ensure data integrity, regulatory compliance, and continued validated system status
• Collaborate with Automation, Quality Assurance, IT/OT, Engineering, and Manufacturing teams
Requirements
• 5+ years of experience with Emerson DeltaV
• Experience with AVEVA / OSIsoft PI System (Process Historians)
• Strong knowledge of SCADA platforms, PLC/HMI controls, and batch applications
• Experience with automation systems and supporting infrastructure
• Hands-on experience with IQ/OQ/PQ protocols and qualification testing
• Strong knowledge of GMP/cGMP, 21 CFR Part 11, and GAMP 5
• Experience with validation documentation, risk assessments, change control, deviations, and CAPA