MF03-050324 Process Development Engineer / Manufacturing Engineer
MF03-050324 Process Development Engineer / Manufacturing Engineer
Validation & Engineering Group, Inc.
Dorado, Puerto Rico
Descubre a quién ha contratado Validation & Engineering Group, Inc. para este puesto
Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
- Process Development Engineer / Manufacturing Engineer
- Manage process development projects from conception to implementation.
- Experience with design of experiments (DOE) to characterize and optimize processes.
- Develop PFMEA methodology for risk analysis.
- Identify areas of improvement in processes and develop strategies to optimize it.
- Support process and/or equipment validation activities (IQ, OQ, PQ); process performance qualification activities and develop Master validation plans for new processes or products.
- Bachelor's Degree in Science or Engineering.
- Minimum of 5 years of experience in direct pharmaceutical, medical device (preferable) or biotechnology industries.
- Must be fully bilingual (English / Spanish) with excellent oral skills.
- Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
- Technical Writing skills and investigations processes.
- Available to work extended hours, possibility of weekends and holidays.
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Nivel de antigüedad
Algo de responsabilidad -
Tipo de empleo
Jornada completa -
Función laboral
Estrategia/planificación y Tecnología de la información -
Sectores
Servicios de ingeniería
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