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
Additional Responsibilities:
Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.
