Assistant Manager, Process Engineering

Amneal Pharmaceuticals; Hyderabad; On-site; INR 1,500,000 - 2,300,000; Full time

Job summary

Amneal Pharmaceuticals is seeking a Senior Process Engineer to lead and manage process engineering activities across pharmaceutical manufacturing operations. You will design, implement, validate, and optimize production processes in line with quality, safety, regulatory compliance, and cost efficiency.

You will interpret process layouts, oversee process validation and scale-up, drive continuous improvement, and provide technical and people leadership to cross-functional teams to ensure audit

Qualifications

• 8+ years of experience in process engineering in pharmaceutical manufacturing.
• Experience with IQ/OQ/PQ and process validation.
• Strong regulatory compliance knowledge (GMP).

Responsibilities

• Lead and oversee process design, optimization, and implementation.
• Ensure IQ/OQ/PQ validation execution and compliance.
• Monitor process performance metrics and KPIs.
• Guide teams on deviation, CAPA, and change control.
• Ensure regulatory compliance and audit readiness.
• Support scale-up, tech transfer, and continuous improvement.
• Coordinate cross-functional production and project activities.
• Review and approve process documentation and validation records.
• Implement risk management and GMP practices.
• Drive lean manufacturing and efficiency improvements.
• Manage resource planning, task allocation, and development.

Skills

Process design

Process validation

KPI monitoring

CAPA & change control

GMP compliance

Lean manufacturing

Team leadership

Education

B.Tech (Bachelor's)

M.Tech (Master's)

Job 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.

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.