- 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.
Qualifications
- BS in Mechanical Engineering
- Bilingual (Spanish & English)
Additional Information
Validation and Engineering Group, Inc. is an Equal Employment Opportunity employer.
About the Company
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.
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