06 Sep
|
Pfizer
|
Visakhapatnam
06 Sep
Pfizer
Visakhapatnam
Use Your Power for Purpose
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.
What You Will Achieve
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.
- Solid documentation and technical writing skills.
- Familiarity with data integrity and audit trail requirements.
- Knowledge of ISA-88 batch control standards.
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📌 Associate Manager (Visakhapatnam)
🏢 Pfizer
📍 Visakhapatnam