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Validation & Engineering Group

Manufacturing Engineer

Caguas, Caguas, pr · On-site · Full-time

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About the role

ComplianceManufacturingMechanical EngineeringQuality AssuranceSpanish
Validation & Engineering Group provides world-class service and expertise to the Biotechnology, Pharmaceutical, Medical Devices, Chemicals (API), Food, and Cosmetics industries.  For over twenty years, V&EG has placed the most talented individuals in a position to make a difference in our customer’s success.  Our services platform is split into four distinct areas: Regulatory Compliance, Validation and Qualification, Laboratory (Validation, Audits), and Engineering (Design Qualification Services), that ensure adherence to Federal and European regulatory agencies. - Site responsible for daily process performance of two tablet coaters and one particle coater in GMP 24-hr pharma manufacturing facility. - Support process development for next generation products, NPIs and transfer products targeting cost reduction and improve process efficiency and safety. - Support QA investigations on Coating, Particle Coating and Drug Weight areas by reviewing the entire process variables, operators interview and identification of root cause if possible. - Identify and implement process improvement opportunities and corrective actions to increase yield and safety, minimize time consumption and decrease process variability while maintaining regulatory compliance. - Daily interaction with Operations (Manufacturing) personal including managers, coordinators, process engineers and operators.   - Interaction with manufacturer representatives to solve process-equipment opportunities. - BS in Mechanical Engineering  - Bilingual (Spanish & English) Validation and Engineering Group, Inc. is an Equal Employment Opportunity employer.