Automation Engineer

Position:

Position Summary

Process Engineer with hands-on experience in Delta DCS systems, PI Historian to support the development and qualification of automation logic, Historian integrations in compliance with 21 CFR Part 11 and the latest validation standards.

The role involves supporting design documents and developing qualification protocols, as well as configuring recipes, formulas, and controlling logic in Delta V DCS system, Historian systems along with Qualifications.

Responsibilities

• Creation of DCS Recipe parameters, Formulas and developing process flows as per Tech transfer inputs.
• Qualification of
• Review and interpret Software Design Specifications (SDS), Functional Specifications (FS), and related documents to understand automation requirements.
• Prepare comprehensive Qualification Documents including - Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)
• Ensure documentation aligns with 21 CFR Part 11, GAMP 5, and internal validation SOPs.
• Develop and configure DeltaV DCS logic, including Batch Recipes, Control Modules, Equipment Modules, Formulas and Phases
• Maintain traceability matrices and ensure audit readiness of all documentation.
• Qualification of Historian systems.

Qualifications & Other requirements

• Bachelors degree in Instrumentation, Automation, Electronics, or related engineering discipline.
• Minimum 4 years of experience in automation engineering within a regulated industry (pharma/biotech preferred).
• Strong working knowledge of DeltaV DCS systems.
• Expertise on 7016 Delta Batch Implementation or equivalent hands-on experience.
• Understanding batch recipes, formulas, and control strategies.
• Solid understanding of 21 CFR Part 11, GAMP 5, and CSV principles.
• Strong documentation and technical writing skills.
• Familiarity with data integrity and audit trail requirements.
• Knowledge of ISA-88 batch control standards.
• Knowledge of ALCOA Principles.
• PI System Architecture Knowledge of PI Data Archive, Asset Framework (AF), Event Frames, and PI Vision.
• Interface Configuration Experience with OPC, Modbus, and other industrial protocols
• Data Modelling & Contextualization Building AF templates and event frames for batch and equipment tracking
• System Integration Connecting PI with MES, ERP & SCADA systems
• Reporting Tools Using PI Datalink, PI Vision, and PI Rt Reports for analytics and compliance reporting