Deputy Manager, Automation

Amneal Pharmaceuticals; Ahmedabad District; On-site; INR 1,400,000 - 2,000,000; Full time

Job summary

Amneal Pharmaceuticals is seeking an experienced Senior Process Engineer to lead manufacturing process engineering activities in Ahmedabad. The role emphasizes design integrity, validation, risk management, and continuous improvement across production operations.

Candidates should have 8+ years in pharmaceutical manufacturing, with preferred exposure to IQ/OQ/PQ validation, tech transfer, and lifecycle management.

Qualifications

• 8+ years in pharmaceutical process engineering/manufacturing.
• Experience in process validation (IQ/OQ/PQ) and tech transfer is preferred.

Responsibilities

• Lead and govern process engineering activities across manufacturing operations.
• Ensure design, validation, and optimization compliance.
• Oversee validation strategies and execution (IQ/OQ/PQ).
• Drive KPI tracking, trend analysis, and process performance monitoring.
• Lead deviation investigations, CAPA, and change control governance.
• Support scale-up, tech transfer, and lifecycle management.
• Ensure regulatory compliance and audit readiness.
• Mentor and develop process engineering teams.

Skills

Process engineering

Quality & regulatory compliance

Risk management

Lean manufacturing

Education

B.Tech

M.Tech

Job 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 strong 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

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