Associate Manager - MSAT

Pfizer; India; On-site; INR 1,200,000 - 2,400,000; Full time

Job summary

Pfizer is seeking a highly experienced Process Engineer to join the Tech Operations team on premise in India. You will apply hands-on DeltaV DCS and PI Historian expertise to support automation design validation and qualification activities, focusing on 21 CFR Part 11, GAMP 5, and CSV compliance.

The role requires clear documentation, development of batch recipes and control strategies, and collaboration with cross-functional teams to transfer technology and ensure audit-ready records.

Qualifications

• Bachelor's degree in Electrical and Electronics, Automation, Chemical or related engineering discipline.
• Minimum 10 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.

Responsibilities

• Create DCS Recipe parameters, Formulas and develop process flows per Tech transfer inputs.
• Review SDS/FS and related docs to understand automation requirements.
• Prepare Qualification Documents: DQ, IQ, OQ, PQ.
• Ensure documentation aligns with 21 CFR Part 11, GAMP 5, and validation SOPs.
• Develop and configure DeltaV DCS logic, including Batch Recipes and Phases.
• Maintain traceability matrices and audit readiness of docs.
• Qualification of Historian systems.
• Understand batch recipes, formulas, and control strategies.
• Familiarity with ISA-88 batch standards and ALCOA principles.
• Interface configuration with OPC, Modbus, and other protocols.
• Data Modeling with AF templates and event frames for batch/equipment tracking.
• System integration with MES, ERP & SCADA.

Skills

DeltaV DCS

PI Historian

Documentation

CSV principles

Data integrity

GAMP 5

ISA-88

ALCOA Principles

Problem solving

Education

Electrical and Electronics / Automation engineering

Tools

OPC

Modbus

PI Data Archive

PI AF

PI Vision

Job description

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.
• 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)

• Bachelor's degree in Electrical and Electronics, Automation, Chemical or related engineering discipline.
• Minimum 10 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.

Bonus Points If You Have (Preferred Requirements)

• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use

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.