Associate Manager - MSAT

About the Role

Join Pfizer's Tech Operations team as an Associate Manager specializing in process engineering, contributing significantly to enhancing patient lives through the development and implementation of advanced automation solutions. This role involves direct involvement with DeltaV Distributed Control Systems (DCS), PI Historian configurations, and adherence to regulatory compliance standards such as 21 CFR Part 11 and GAMP 5.

Key Responsibilities

• Develop DeltaV DCS recipe parameters, formulas, process flows aligned with technology transfer inputs.
• Analyze and interpret Software Design Specifications (SDS), Functional Specifications (FS), and related automation documentation.
• Create detailed qualification documentation including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Ensure compliance and alignment of all documents with 21 CFR Part 11, GAMP 5, and internal validation Standard Operating Procedures (SOPs).
• Design and configure DeltaV DCS logic including batch recipes, control modules, equipment modules, and process phases.
• Maintain thorough traceability matrices and prepare for audits ensuring all documentation is audit-ready.
• Perform qualification activities for Historian systems and integrate these with automation solutions.
• Apply a strong understanding of batch recipes, formulas, control strategies, and ISA-88 batch control standards.
• Adhere to ALCOA principles, data integrity, and audit trail requirements in documentation and system configurations.
• Configure PI System Architecture components like PI Data Archive, Asset Framework (AF), Event Frames, and PI Vision.
• Manage interface configurations using industrial protocols such as OPC and Modbus.
• Build data models and contextualize data via AF templates and event frames for batch and equipment tracking purposes.
• Integrate PI systems with MES, ERP, and SCADA systems to ensure seamless operations.
• Utilize reporting tools such as PI Datalink, PI Vision, and PI Rt Reports for analytics and compliance reporting.

Qualifications and Experience

• Bachelor's degree in Electrical and Electronics, Automation, Chemical Engineering, or related disciplines.
• At least 10 years of professional experience in automation engineering within regulated industries, preferably pharma or biotech.
• Expertise and hands-on experience with DeltaV DCS systems and 7016 Delta Batch Implementation or equivalent platform.

Preferred Skills and Bonus Points

• Experience leveraging AI technologies, including generative models like ChatGPT or Microsoft Copilot, to enhance problem-solving and productivity.
• Demonstrated curiosity for responsible AI adoption focusing on risk management and ethical usage.

Work Location

This position requires onsite presence in Visakhapatnam, Andhra Pradesh, India.

Equal Opportunity and Compliance

Pfizer is committed to equal employment opportunities and complies with all applicable employment legislation. Candidates are advised to familiarize themselves with Pfizer's AI use guidelines during recruitment for acceptable and prohibited AI application.