Process Engineering Lead - DeltaV, Validation & Compliance

Pfizer, S.A. de C.V

Hinoba-an

On-site

PHP 800,000 - 1,200,000

Full time

34 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

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.

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