Facilities Engineer
Aviso de fuente externaen Indotronix Avani Group
Experience in pharma, bio tech, med device Must have facility validation experience HIPPA filtration Must have experience in writing protocols 6+ years of experience. Bachelor's Degree is...
Salario
No especificado
Ubicación
Anasco, PR
Tipo de empleo
Tiempo completo
Modalidad
No especificado
Facilities Engineer
Anasco, PR
Descripción del empleo
Experience in pharma, bio tech, med device Must have facility validation experience HIPPA filtration Must have experience in writing protocols 6+ years of experience. Bachelor's Degree is required. Responsibilities: Plans, develops, and implements documentation, procedures, and trainings necessary for the engineering team.Actively participate in the Validation Life Cycle of regulated projects by reviewing validation documentation, participating in application requirements definition, risk assessments, traceability matrix, validation protocol development, validation testing and deviation management.Must be able to generate Validation Plans, User Requirement Specifications (URS), Functional Requirement Specifications (FRS), System Design Specifications (SDS), traceability matrix and validation protocols (IQ/OQ/PQ).Able to develop technical documentation such as: Change Controls, Validation Plans, Validation Protocols, Technical / investigation reports, SOP, and others. Teamwork oriented and self-starter.
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