Associate Manager - MSAT

Job Overview

As a Process Engineer on the Tech Operations team, you will contribute significantly to enhancing patient outcomes by developing and supporting innovative automation solutions at Pfizer. Your efforts will ensure the delivery of high-quality products that improve patients' lives globally.

Key Responsibilities

• Develop and configure DeltaV DCS system components including batch recipes, control modules, equipment modules, formulas, and phases according to technology transfer inputs.
• Interpret and review software design specifications (SDS), functional specifications, and related documents to fully understand automation requirements.
• Create comprehensive qualification documentation covering design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
• Ensure all documentation is compliant with regulatory standards including 21 CFR Part 11, GAMP 5, and internal validation standard operating procedures.
• Maintain traceability matrices and keep documentation audit-ready.
• Support integration and qualification of PI Historian systems and historian integrations.
• Understand and implement batch control strategies in line with ISA-88 standards.
• Configure interfaces using protocols such as OPC and Modbus for system integration.
• Build AF templates and event frames for batch and equipment tracking within PI System architecture.
• Use reporting tools like PI Datalink, PI Vision, and PI Rt Reports for data analytics and compliance reporting.

Minimum Qualifications

• Bachelor’s degree in Electrical and Electronics, Automation, Chemical, or a related engineering field.
• At least 10 years of professional experience in automation engineering within regulated sectors such as pharmaceutical or biotechnology.
• Strong expertise with DeltaV DCS systems, specifically with hands-on experience in 7016 Delta Batch Implementation or equivalent.

Preferred Attributes

• Familiarity with AI tools such as ChatGPT or Microsoft Copilot to aid problem-solving and improve productivity.
• Demonstrated interest in applying AI responsibly, including understanding risk management and ethical considerations.

Additional Details

This position is based onsite at Visakhapatnam Rural mandal, India. Pfizer is committed to equal employment opportunities and adheres strictly to applicable equal opportunity laws. Candidates are encouraged to review Pfizer's guidelines on responsible AI use during recruitment.