Description

Description:

The role is responsible for leading and managing process engineering activities across pharmaceutical manufacturing operations. The role ensures design, implementation, validation, and optimization of production processes in line with quality, safety, regulatory compliance, cost efficiency, and performance standards. It involves interpreting process layouts, drawings, specifications, and SOPs, overseeing process validation and scale-up activities, and ensuring robust process control and audit readiness.

The position provides technical and people leadership, supports cross-functional coordination, and drives continuous improvement initiatives. The role contributes to reliable, compliant, and effective manufacturing operations by applying engineering standards, regulatory guidelines, and performance-driven process governance.

Essential Functions:
Lead and oversee process design, optimization, and implementation activities
Ensure process validation (IQ/OQ/PQ) execution and compliance
Monitor process performance metrics,



KPIs, and operational trends
Guide teams on process troubleshooting, deviation, CAPA, and change control management
Ensure regulatory compliance and quality audit readiness of production processes
Support process scale-up, technology transfer, and continuous improvement initiatives
Coordinate with cross-functional teams for production and project activities
Review and approve process documentation, reports, and validation records
Implement risk management, safety engineering, and GMP practices
Drive lean manufacturing and efficiency improvement initiatives
Manage resource planning, task allocation, and team development

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:

📌 Assistant Manager, Process Engineering Hyderabad (India)
🏢 Amneal
📍 India