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
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:
About Us
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.
About The Team
The
Human Resources team partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs.
Key Roles That The Human Resources Team Performs
Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions.
Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures.
Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing.
Consultancy Role: Provide expert advice to the organization and it’s managers on any aspect of workforce management and employee relations and performance.
Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market.
