Associate Manager, MSAT Automation
ROLE OVERVIEW
This Associate Manager – MSAT role at Pfizer’s Vizag manufacturing site sits at the intersection of process automation, validation, and compliant digital manufacturing. You will support tech transfer and commercial supply by configuring DeltaV DCS recipes and PI Historian systems, generating qualification documents, and ensuring 21 CFR Part 11, GAMP 5, and data integrity standards. The position is critical to Pfizer’s ability to deliver high-quality medicines reliably, as automation logic and historian data underpin batch release and regulatory audit readiness. For experienced automation engineers, this is a compelling opportunity to work with global biopharma standards, advanced DCS/Historian platforms, and cross-functional MSAT teams, while building a career in regulated manufacturing technology and digital operations.
ROLE DEFINITION & RESPONSIBILITIES
- •Create DCS recipe parameters, formulas, and process flows based on tech transfer inputs and manufacturing requirements.
- •Review and interpret Software Design Specifications (SDS), Functional Specifications (FS), and related automation documents.
- •Prepare and execute qualification documents including DQ, IQ, OQ, and PQ for DeltaV DCS and PI Historian systems.
- •Configure DeltaV batch recipes, control modules, equipment modules, formulas, and phases in line with ISA-88 standards.
- •Maintain traceability matrices and ensure audit readiness for all automation and validation documentation.
- •Qualify PI Historian architecture, including PI Data Archive, Asset Framework, Event Frames, and PI Vision.
- •Integrate PI systems with MES, ERP, and SCADA using OPC, Modbus, and other industrial protocols.
- •Ensure compliance with 21 CFR Part 11, GAMP 5, CSV principles, ALCOA, and data integrity requirements.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Bachelor’s degree in Electrical and Electronics, Automation, Chemical, or related engineering discipline.
- Minimum 10 years of automation engineering experience in a regulated industry, preferably pharma/biotech.
- Strong working knowledge of DeltaV DCS systems and batch implementation.
- Expertise in 7016 – Delta Batch Implementation or equivalent hands-on experience.
- Experience creating and reviewing DQ, IQ, OQ, PQ, and validation lifecycle documents.
- Solid understanding of 21 CFR Part 11, GAMP 5, CSV, and data integrity requirements.
- Strong technical writing and documentation skills.
PREFERRED QUALIFICATIONS
- •Experience with AI tools such as ChatGPT or Microsoft Copilot
- •Responsible AI practices and risk management
- •PI DataLink, PI Vision, and PI Rt Reports
- •Project management in regulated manufacturing
- •Cross-functional collaboration with MSAT, QA, and Engineering
REQUIRED VERIFIED SKILLS
COMPENSATION & REWARDS
ORGANIZATION CONTEXT & CULTURE
Pfizer Inc. is an American multinational pharmaceutical and biotechnology corporation. It is dedicated to the discovery, development, manufacturing, marketing, and sale of medicines and vaccines worldwide. The company focuses on breakthrough science to deliver innovative treatments across various therapeutic areas to improve health outcomes.
EXPECTED CAREER ROADMAP
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