Pfizer
India - Vizag
As a Process Engineer , you will be part of Tech Operations team and play a crucial role in improving patients' lives while working at Pfizer. Your contributions will directly impact the development and delivery of innovative solutions that enhance the quality of life for patients worldwide. Join us in our mission to bring breakthroughs that change patients' lives.
In this role, you will work as 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.
Key Responsibilities:
Creation of DCS Recipe parameters, Formulas and developing process flows as per Tech transfer inputs.
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.
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 Modeling & 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.
Here Is What You Need (Minimum Requirements)
Bonus Points If You Have (Preferred Requirements)
Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.
Engineering