Description
JOB 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
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.
