Description

JOB DESCRIPTION

The role is responsible for leading, governing, and optimizing pharmaceutical manufacturing processes across production operations. The role ensures process design integrity, validation compliance, operational robustness, and continuous improvement in line with quality, safety, regulatory, cost, and performance standards. It involves reviewing process layouts, specifications, validation strategies, and performance outcomes, overseeing scale-up and technology transfer, and ensuring audit-ready operations. The position provides robust technical and people leadership, drives process governance, risk management, and performance monitoring, and ensures adherence to engineering standards, SOPs, and regulatory requirements to support reliable and compliant manufacturing.

Essential Functions
Lead and govern process engineering activities across manufacturing operations
Ensure process design, validation, and optimization compliance
Oversee process validation (IQ/OQ/PQ) and validation strategy execution




Drive process performance monitoring, KPI tracking, and trend analysis
Lead deviation, investigation, CAPA, and change control governance
Support process scale-up, technology transfer, and lifecycle management
Ensure regulatory compliance and quality audit readiness
Review and approve process documentation, validation reports, and SOPs
Implement risk management, FMEA, and safety engineering practices
Drive continuous improvement, lean manufacturing, and efficiency initiatives
Coordinate with cross-functional stakeholders and senior leadership
Lead, mentor, and develop process engineering teams

Additional Responsibilities

QUALIFICATIONS

Education
Bachelors Degree (BA/BS) B.Tech - Required
Master Degree (MS/MA) M.Tech - Preferred

Experience:
8 years or more in 8 - 10 Years

Specialized Knowledge: Licenses:

📌 Deputy Manager, Automation Ahmedabad
🏢 Amneal Pharmaceuticals
📍 Ahmedabad