Process Engineer

Responsibilities

• Design, develop, and optimize manufacturing processes.
• Implement improvements in efficiency, quality, and cost using Lean Manufacturing, Six Sigma, and Design of Experiments (DOE) methodologies.
• Prepare and execute process and equipment validation protocols (IQ/OQ/PQ) according to regulatory requirements.
• Define, control, and monitor Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs).
• Investigate process deviations and lead Corrective and Preventive Actions (CAPA).
• Coordinate technology transfer activities from R&D to manufacturing.
• Develop and maintain technical documentation such as work instructions, process flow diagrams, validation reports, and SOPs.
• Participate in internal and external audits (FDA, ISO, COFEPRIS, or other regulatory bodies).
• Ensure full traceability of materials, equipment, and production batches in compliance with medical ...