Ingeniero en microbiología y esterilización

807683

Salario confidencial CRC

Toda Costa Rica

Publicado 21 Jul 2021

Consumo masivo / Otras

1 Vacante

Ingeniería Industrial / Otras


Sector de la vacante:
Industrias manufactureras

Descripción general

SUMMARY:
Coordinates and executes Sterilization Validation activities for both EtO Sterilization and Radiation Sterilization (including E-Beam). Collaborates / Approves in writing of Sterilization Protocols. Collaborates / Approves procedures and work instructions relative to sterilization, environmental control, GMPs for clean rooms and white rooms. Support and/or executes action items, risk assessments and CAPAs related to Sterilization and Environmental Controls. Supervises Quality Release duties, associated with process documents review, sterilization control, certificates generation and product verification required for product release.
Collaborate with Quality system audits, including training audits, GMPs and GDPs, workstation practices, etc.

EDUCATION AND/OR EXPERIENCE: Bachelor degree or higher in Biotechnology Engineering, Biomedical Engineering, Microbiology, Biology or related field. Preferably more than 6 months in the medical device industry. Preferably, basic experience or knowledge of sterilization of medical devices.

Requisitos para aplicar

ESSENTIAL DUTIES AND RESPONSABILITIES include the following. Other duties may be assigned.
? Coordinates Sterilization validation and re-validation activities
? Collaborates / Approves writing and reviewing Sterilization and Environmental controls documents including procedures , protocols, work instructions, drawing, forms, etc.
? Responsible for monitoring sterilization results and environmental control results including: PCDs trends, LAL trends, Bioburden trends, microorganism IDs, other Laboratory testing results.
? Responsible for assessing product contamination risks and conducting investigation and CAPAs related to Microbiology Hazards and physical contamination of product.
? Responsible for leading biocompatibility assessments of products.
? Responsible for assessing Environmental Controls of CERs and White Rooms, including Alert and Action limits for Viable and Non-viable particles, Fungal, Bioburden, etc.
? Responsible for assessing cleaning activities in the CCER and White Room.
? Supervises quality release tasks.
? Responsible for supporting sterilization tasks.
? Support quality system audit activities.
? Other duties in the Quality Assurances area.

Datos complementarios

807683

Profesional

Encargado

Bachillerato universitario

Manufacturas varias

1 año de experiencia

Contrato Indefinido

807683

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