Associate Manager - MSAT
Pfizer · Vizag, India
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Role summary
Pfizer seeks a Process Engineer for their Tech Operations team in Vizag, India to design and qualify automation systems for pharmaceutical manufacturing. The role involves configuring Delta DCS systems, PI Historian platforms, and developing comprehensive validation documentation compliant with FDA regulations and industry standards.
What they're looking for
- Bachelor's degree in electrical, electronics, automation, chemical or related engineering
- Minimum 10 years automation engineering experience in regulated pharma or biotech industry
- Strong working knowledge of DeltaV DCS systems and batch implementation
- Expertise in 21 CFR Part 11, GAMP 5, and CSV validation principles
- Proficiency with PI System architecture and data modeling concepts
- Knowledge of ISA-88 batch control standards and ALCOA principles
- Experience configuring industrial protocols such as OPC and Modbus
What you'll be doing
- Create DCS recipe parameters, formulas, and process flows based on technology transfer requirements
- Develop qualification documents including DQ, IQ, OQ, and PQ in compliance with regulatory standards
- Configure DeltaV DCS logic including batch recipes, control modules, equipment modules, and phases
- Qualify Historian systems and ensure system integration with MES, ERP, and SCADA platforms
- Maintain traceability matrices and ensure all documentation meets audit readiness requirements
Privacy & handoff
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