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 stable, compliant, and efficient 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:
- Bachelors Degree (BA/BS) B.Tech - Required
- Master Degree (MS/MA) M.Tech - Preferred
- 8 years or more in 8 - 10 Years