Job Description

This is a full-time position to work Monday to Friday from 8am to 5pm in our Heredia site located in Heredia, Zona Franca Metropolitana.

Our Microbiology Technicians 3 are responsible to support environmental control activities, executing environmental routine testing for viable and non-viable particles for air and product contact surfaces follow quality system and in compliance with Good manufacturing practices.

Main Job Duties:

• All duties listed for category 1 and 2.
• Perform investigation process for out of tolerance equipment.
• Include new equipment at the calibration and maintenance system.
• Review and approve cleanroom intrusion plans.
• Get involved in various stages of equipment and processes validations: run or write protocols and reports for IQ, OQ, PQ and TMV; as well as any other document relating to validation.
• Performs or coordinate microbiology testing as offered by the Microbiology Lab, including LAL, Bioburden, Environmental monitoring.
• Performs other duties, tasks, or projects at the direction of the immediate supervisor or other teammates.
• Establishes and ensures compliance with good housekeeping practices, employee hygiene, and equipment sanitation.
• Participate, lead and propose new VIP projects providing guidance for other areas as Engineering, Facilities, and Production and into the microbiology area implementing VIP projects.
• Create new part numbers for non-BOM items as required, develop new item specifications to be included on the Component Specifications.

Knowledge / Education

• Microbiology or Quality Technician. Biotechnology, Microbiology and Biology Bachelor degree is a plus.
• Microsoft office basic knowledge is required
• Bilingual English/Spanish – Intermediate English level.
• Knowledge on FDA Quality System Regulation, Medical Device Directive, ISO 13485, process validation requirements.
• Knowledge of GMPs, ISO, USP and FDA regulations as they relate to laboratory operations and investigations and sterilization is a plus.
• Knowledge and application of statistical techniques (basic descriptive statistics).
• Knowledge in root cause analysis tools.
• Knowledge of Minitab statistical software.

Work Experience

• More than 4 years of experience within the medical device or pharmaceutical in the monitoring and control of clean room environments field.

Skills / Competencies

Ability to handle and operate environmental control and microbiology equipment.

Focus on details, priorities management.

Analytical and organized person

Maintain effective working relations with all departments.

Proactive

Customer oriented

Ability to work independently and follow both verbal and written instructions

Effective planning and time management

Decision making

Analytical

Innovative

Physical Demands

Moderate carry capacity of environmental control equipment moving between buildings.

Perform repetitive tasks, such as reviewing and typing multiple reports.

Viant es un proveedor global de servicios de diseño y fabricación de dispositivos médicos que se asocia e innova con los clientes para proporcionar la más alta calidad, dispositivos médicos que mejoran la vida de las personas. Hacemos esto a través de nuestra profundidad y amplitud de capacidades, integración de extremo a extremo, experiencia técnica y enfoque implacable en nuestros clientes y en la excelencia operativa. Con casi 6.000 asociados en 24 ubicaciones en todo el mundo, ofrecemos una combinación única de servicio y atención a pequeñas empresas con recursos de grandes empresas. Para más información, visite viantmedical.com o síganos en LinkedIn.

Viant proporciona igualdad de oportunidades de empleo (EEO) a todos los empleados y solicitantes de empleo sin tener en cuenta la raza, color, religión, género, orientación sexual, nacionalidad, edad, discapacidad, estado civil, amnistía, o estatus como veterano cubierto de acuerdo con las leyes federales, estatales y locales aplicables. Viant cumple con las leyes estatales y locales aplicables que rigen la no discriminación en el empleo en todos los lugares en los que la empresa tiene instalaciones.