Associate Manager - MSAT

Biopharma Careers; Visakhapatnam; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Pfizer is seeking a Process Engineer to support automation development and qualification in DeltaV DCS and Historian systems. You will work on batch recipes, control modules, and integration with MES/ERP/SCADA as part of tech transfer agreements.

You will prepare DQ/IQ/OQ/PQ documentation and ensure compliance with 21 CFR Part 11 and GAMP 5. Strong writing and data integrity knowledge are essential.

Qualifications

• Bachelor’s degree in Electrical and Electronics, Automation, Chemical or related engineering discipline.
• 10+ years in automation engineering within regulated pharma/biotech is preferred.
• Strong DeltaV DCS knowledge and Delta Batch implementation experience.

Responsibilities

• Create DCS recipe parameters, formulas and process flows per tech transfer inputs.
• Review SDS/FS and related docs to understand automation requirements.
• Prepare Design, Installation, Operational, and Performance Qualification documents (DQ/IQ/OQ/PQ).
• Ensure documents align with 21 CFR Part 11, GAMP 5, and validation SOPs.
• Develop and configure DeltaV DCS logic including batch recipes and control modules.
• Maintain traceability matrices and audit-ready documentation.

Skills

Documentation

Regulatory awareness

Batch understanding

Education

Bachelor’s degree in Electrical & Electronics / Automation / Chemical engineering

Tools

DeltaV DCS

PI System

OPC/Modbus interfaces

PI Datalink

PI Vision

PI Historian

Job description

Use Your Power for Purpose

What You Will Achieve

In this role, you will work as Process Engineer with hands-on experience inDelta DCS systems, PI Historian to support the development and qualification of automation logic, Historian integrations in compliance with21 CFR Part 11andthe 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 interpretSoftware Design Specifications (SDS),Functional Specifications (FS), and related documents to understand automation requirements.
• Prepare comprehensiveQualification Documentsincluding - Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ),Performance Qualification (PQ)
• Ensure documentation aligns with21 CFR Part 11,GAMP 5, and internal validation SOPs.
• Develop and configureDeltaV DCSlogic, 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, andcontrol strategies.
• Solid understanding of21 CFR Part 11,GAMP 5, andCSVprinciples.
• Strong documentation and technical writing skills.
• Familiarity withdata integrityandaudit trailrequirements.
• Knowledge ofISA-88batch 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 inElectrical and Electronics, Automation,Chemical or related engineering discipline.
• Minimum10 years of experiencein automation engineering within a regulated industry (pharma/biotech preferred).
• Strong working knowledge ofDeltaV DCS systems.
• Expertise on 7016 – Delta Batch Implementationor 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, includingrisk 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 onPfizer Careers .

Engineering