Title:Process Engineer
Location:Madurai Manufacturing
Family:Engineering
The Process Engineer is responsible for providing technical leadership and subject matter expertise in process validation, cleaning validation, packaging validation, equipment qualification, manufacturing process optimization, and commercialization activities within pharmaceutical and nutraceutical manufacturing operations.
The role drives process robustness, product quality, regulatory compliance, operational excellence, and lifecycle management through validation, equipment qualification, process monitoring, troubleshooting, risk management, and continuous improvement initiatives. The position serves as the technical owner for manufacturing and packaging process performance and supports successful transfer of validated processes into routine commercial operations.
The role works closely with Manufacturing, Packaging, Quality Assurance, Quality Control, Supply Chain, Project Engineering, EHS, Procurement, Regulatory Affairs, and R&D; functions to ensure secure, compliant, and efficient manufacturing operations.
PRIMARY RESPONSIBILITIES
Validation, Qualification & CQV
- Lead and execute CQV, IQ, OQ, PQ, process validation, cleaning validation, packaging validation, and hold-time studies.
- Develop validation strategies, protocols, reports, and qualification documentation.
- Support qualification of facilities, utilities, instrumentation, automation, and computerized systems.
- Apply risk-based validation principles and ensure compliance with GMP and Data Integrity requirements.
Manufacturing & Packaging Process Engineering
- Provide technical ownership of manufacturing and packaging processes throughout the product lifecycle.
- Establish and maintain process centerlines, critical process parameters, and process controls.
- Support formulation, encapsulation, coating, drying, blending, and packaging operations through engineering studies and performance assessments.
- Evaluate packaging equip
📌 Process Engineer (Madurai)
🏢 Amway
📍 Madurai