Description

Description:Ther role is accountable for leading the design, development, implementation, and optimization of pharmaceutical manufacturing processes to ensure effective, 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:

Qualifications

Education:
Bachelors Degree (BA/BS) B.E.
Required
Master Degree (MS/MA) ME - Preferred

Experience:
15 years or more in 15+ Years

Specialized Knowledge: Licenses:

📌 Senior Manager, Process Engineering Hyderabad
🏢 Amneal
📍 Hyderabad