Microbiology & Steril Technician 1 CR

Costa Rica·Alajuelamid

OtherTechnician

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Quick Summary

Key Responsibilities

Monitor the controlled environment room, laundry, laminar flow hoods, air and water systems. Coordinate routine microbiology analysis with external laboratories.

Technical Tools

OtherTechnician

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

Education / Educación: Graduated from Vocational Technician or completed Technical Program (350 hours minimum) or with 25% of a bachelor’s degree on related career.

Experience / Experiencia: no experience is required in similar positions.

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 internetSummary 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
- Education / Educación: Graduated from Vocational Technician or completed Technical Program (350 hours minimum) or with 25% of a bachelor’s degree on related career.
- Experience / Experiencia: no experience is required in similar positions.
- 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 internetSummary 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
  - Education / Educación: Graduated from Vocational Technician or completed Technical Program (350 hours minimum) or with 25% of a bachelor’s degree on related career.
  - Experience / Experiencia: no experience is required in similar positions.
  - 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 internetSummary 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
    - Education / Educación: Graduated from Vocational Technician or completed Technical Program (350 hours minimum) or with 25% of a bachelor’s degree on related career.
    - Experience / Experiencia: no experience is required in similar positions.
    - 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 internetSummary 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
      - Education / Educación: Graduated from Vocational Technician or completed Technical Program (350 hours minimum) or with 25% of a bachelor’s degree on related career.
      - Experience / Experiencia: no experience is required in similar positions.
      - 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 internetSummary 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
        
        Education / Educación: Graduated from Vocational Technician or completed Technical Program (350 hours minimum) or with 25% of a bachelor’s degree on related career.
        
        Experience / Experiencia: no experience is required in similar positions.
        
        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