Process Engineer

·       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 industry standards.

·       Collaborate with Quality, Production, Maintenance, and Regulatory Affairs teams to ensure process compliance.

·       Identify opportunities for continuous improvement and lead innovation and automation projects.