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Ingeniero De Validaciones
Jero Management Group Inc
Lugar de Empleo:
Ceiba Norte Industrial Park, Juncos
Número de Vacantes:
1
Sector:
Ingeniería / Tecnicatura
Rango de Edad:
Entre 30 y 50
Género:
Indistinto
Nivel de Educación:
Universitario (Graduado)
Idioma Requerido para el Empleo:
Inglés
Años de Experiencia:
7
Tipo de Puesto:
Contrato
Descripción del Empleo:
Validations Engineer - will work with our Clients and be responsible for preparing and executing validation documents. Demonstrate an understanding of cGMP. Individuals must represent the company and division at client sites and interact confidently with clients, contractors, management and peers. Protocol development skills will include ability to develop Installation, Operational and Performance qualification documents. Essential Duties and Responsibilities include, but are not limited to, the following: • Design, develop, and prepares validation protocols for manufacturing and packaging processes, as well as cleaning processes. • Design, develop, and prepare documents, such as: Design Review Procedure, Design Specifications, Functional Specifications, User Requirement Specifications, Factory Acceptance Tests, Impact Assessments, Maintenance Plans, etc. • Compile/Analyze analytical validation data and test results and prepare documentation for FDA compliance. • Provide necessary evidence to support proof that manufacturing, packaging, and cleaning systems/processes consistently result in products or processes that meet established specifications and quality standards. Education and Experience: • Requires a BS in Engineering with at least 7 years of experience in the Pharmaceutical Industry, preferable on Medical Devices. • Candidates must have excellent verbal communication and technical writing skills on both: English and Spanish. • Proficient in Microsoft Word, Excel and Power Point. • Ability to plan and manage own work.
Fecha de Publicación:
02 de Mayo de 2014
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