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Microbiology & Steril Technician 1 CR

Hologic Careers
Alajuela, Costa RicaPosted 1 weeks ago
remote
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Job Description

  • 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

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About Hologic Careers
Microbiology & Steril Technician 1 CR at Hologic Careers | Renata