Microbiology & Steril Technician 1 CR (Temporary 6 months)
Hologic
A tiempo completo
En el sitio
Costa Rica
Description
- Education / Educación: Graduated from Vocational Technician or completed Technical Program (350 hours minimum) or with 25% of a bachelor’s degree on related career.
- Specialized Knowledge (Desirable) / Conocimiento especializado (preferible):
- Preparation of microbiological cultures.
- Aseptic techniques.
- Environmental and microbiological testing, related to monitoring of controlled areas, water, product bioburden.
- Preparation and testing of biological indicators for sterilization processes
- FDA regulations, ISO 13485, ISO 14644, ISO 14698, ISO 11135, ISO 11137, TIR 28, TS 13004, and related ISO and AAMI standards.
- Operation, validation and adoption sterilization processes.
- Experience in transfer or new product introduction projects.
- Languages required for the position (Desirable) / Idiomas requeridos para el puesto (preferible): Spanish/English (Intermediate).
- Computer tools and knowledge level required (Desirable) / Herramientas informáticas y nivel de conocimiento requerido:
- Basic Microsoft Office package: Intermediate
- MS Project: Intermediate
- E-mail and internet
- Summary of Duties and Responsibilities / Resumen de funciones y responsabilidades:
- Monitor the controlled environment room, laundry, laminar flow hoods, air and water systems.
- Coordinate routine microbiology analysis with external laboratories.
- Coordinate with vendors such as sterilizers and external microbiology laboratories, for different special testing requirements.
- Support sterilization projects.
- Support/plan/execute cost and/or time effective continuous improvement initiatives for the Microbiology Lab and the routine activities performed.
- Plan and/or executed microbiological validations.
- Plan, coordinate or perform the dose audits and bioburden testing.
- Support the sterilization process requalifications or/and Annual Sterilization Assessment.
- Support and execute assessments related to sterilization processes (if applicable).
- Support Microbiology investigations related to NCEs, IACAs and CAPAs, etc.
- Product release support regarding events related to sterilization parameters or deviation events.
- Support impact assessments related to changes that could affect the effectiveness of the sterilization process.
- Create Purchase Orders for services, supplies and others, and verify invoice payment.
- Ensure availability of laboratory supplies, product samples, and culture media to perform microbiological and sterilization testing.
- Coordinate and/or perform Training Programs for GMPs.
- Qualifications / Cualificaciones:
- Drive for Results
- Planning
- Organizational Agility
- Listening
- Decision Quality
- Problem Solving