Associate Manager - MSAT

Pfizer, S.A. de C.V

Hinoba-an

On-site

PHP 800,000 - 1,200,000

Full time

36 hours ago
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Job summary

Pfizer is seeking a Process Engineer to join Tech Operations and enhance automation across DeltaV DCS and PI Historian platforms. You will shape validation, design, and qualification efforts, ensuring compliant documentation and robust batch control strategies.

The role requires deep expertise in DCS system configuration, device interfaces, and cross-functional collaboration to support pharmaceutical manufacturing excellence and data integrity across validated systems.

Qualifications

  • Bachelor’s degree in Electrical and Electronics, Automation, Chemical or related engineering.
  • Minimum 10 years of experience in automation engineering within a regulated pharma/biotech environment.
  • Strong working knowledge of DeltaV DCS systems and PI Historian.

Responsibilities

  • Create DCS Recipe parameters, Formulas and develop process flows from tech transfer inputs.
  • Review and interpret SDS/FS to understand automation requirements.
  • Prepare qualification documents (DQ, IQ, OQ, PQ) and ensure validation compliance.
  • Ensure documentation aligns with 21 CFR Part 11 and GAMP 5 SOPs.
  • Develop and configure DeltaV DCS logic, including Batch Recipes and Modules.
  • Maintain traceability matrices and audit readiness of all documentation.
  • Qualification of Historian systems and data integrity checks.
  • Interface configuration with OPC and Modbus, and other industrial protocols.
  • Data modeling with AF templates and event frames for batch tracking.
  • System integration with MES, ERP and SCADA systems.
  • Reporting using PI Datalink, PI Vision, and PI Rt Reports for analytics.

Skills

DeltaV DCS
PI Historian
Historian systems
GAMP 5
21 CFR Part 11
Documentation
Technical writing
Quality systems
ISA-88 batch control
OPC/Modbus interfaces
System integration

Education

Bachelor's degree in Electrical and Electronics
Automation Engineering
Chemical Engineering

Tools

DeltaV DCS
PI System (AF, Data Archive, Vision)
PI Datalink/PI Rt Reports
SDS/FS review tools

Job description

We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.

Pfizer Global Supply proudly shoulders the responsibility of manufacturing and distributing our wide-ranging pharmaceutical products.

Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.

Transforming Delivery of high quality products

Pfizer, We are one

PGS - Manufacture the Future

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 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.
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

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 .

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