Validation & Engineering Group, Inc.

MF03-050324 Process Development Engineer / Manufacturing Engineer

Validation & Engineering Group, Inc. Dorado, Puerto Rico
Validation & Engineering Group, Inc.

MF03-050324 Process Development Engineer / Manufacturing Engineer

Validation & Engineering Group, Inc. Dorado, Puerto Rico
Hace 4 meses 45 solicitudes

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:

  • Process Development Engineer / Manufacturing Engineer

Responsibilities

  • 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.

Qualifications

  • 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.

  • 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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