Senior Manager, Process Engineering

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

Job summary

Amneal in Hyderabad, India seeks an experienced professional to lead the design, development, and optimization of pharmaceutical manufacturing processes for scalable, compliant mass production. The role partners with Manufacturing, Quality, R&D and Engineering to enable technology transfer, continuous improvement, and data-driven decisions.

You will drive risk management, CAPA, and validation activities, oversee equipment selection, and ensure audit readiness.

Qualifications

• Strong expertise in design, optimization, and validation of manufacturing processes.
• Experience with CAPA, deviation investigations, and root cause analysis.
• Proven ability to lead cross-functional teams across Manufacturing, Quality, R&D and Engineering.

Responsibilities

• Lead process design, optimization, and manufacturing layout planning.
• Oversee process scale-up, technology transfer, and validation activities.
• Ensure regulatory compliance and GMP adherence across processes.
• Govern process validation strategies, IQ/OQ/PQ, and master plans.
• Drive deviation investigations, CAPA, and root cause analysis.
• Monitor KPIs, yields, and performance metrics.
• Support equipment selection, installation, and automation integration.

Skills

Process design

Process optimization

Regulatory compliance

GMP adherence

Risk management

Team mentoring

Tools

MES/eBR integration tools

Vision systems

Job description

Description:Ther role is accountable for leading the design, development, implementation, and optimization of pharmaceutical manufacturing processes to ensure efficient, economical, scalable, and compliant mass production. The role provides strategic direction across process design, equipment layout, scale-up, and validation activities while ensuring regulatory compliance and product quality. This position drives process robustness, risk management, and operational excellence across the product lifecycle. The role partners with Manufacturing, Quality, R&D, and Engineering teams to enable technology transfer, continuous improvement, and data-driven decision-making. The role also ensures audit readiness, performance optimization, and sustainable manufacturing practices aligned with business and regulatory expectations.

Essential Functions:

• Lead process design, optimization, and manufacturing layout planning
• Oversee process scale-up, technology transfer, and commercialization activities
• Ensure regulatory compliance and GMP adherence across processes
• Govern process validation strategies, IQ/OQ/PQ, and master plans
• Drive deviation investigations, CAPA, and root cause analysis
• Monitor process KPIs, yields, and performance metrics
• Support equipment selection, installation, and automation integration
• Lead risk management, FMEA, and safety assessments
• Ensure quality, audit readiness, and inspection support
• Mentor teams and enable training and competency development
• Manage preventive maintenance of critical process equipments: RMG/FB/Fluid Bed Processor, Blenders, CAD Mill, Compression, Encapsulation, Auto-coaters,
• Vision/Checkweighers
• Recommend vision systems and MES/eBR integration tools for process control
• Support in investigations for blend uniformity, weight variation, lamination/capping, sticking/picking, dissolution failures, friability/coating defects
• Approve equipment URS, FAT/SAT and support IQ/OQ/PQ from a process perspective

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.

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 its 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.