Hologic, Inc.

Microbiology & Steril Technician 1 CR

Hologic, Inc.  •  Alajuela, CR (Onsite)  •  4 days ago
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Job Description

  • 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 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 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 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 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 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
Hologic, Inc.

About Hologic, Inc.

We’re an innovative medical technology company whose purpose is to enable healthier lives everywhere, every day. While we discover and develop groundbreaking products and services that benefit everyone, we are especially passionate about those that advance women’s health and well-being. This allows us to be a company that prospers, grows and empowers women to experience healthier lives.

None of this would be possible without the talent, skills and aspirations of our employees. Their expertise and dedication to developing and sharing more robust, science-based certainty drives our increasingly global presence, as well as a pipeline that responds to the unmet health and wellness needs of women, families and communities.

What powers our growth across Breast & Skeletal Health, Diagnostic Solutions, and GYN Surgical Solutions is also what differentiates us: the exceptional and clinically proven ability of our products to detect, diagnose and treat illnesses and other health conditions earlier and better. This clinical superiority creates high expectations, which we fulfill by always challenging ourselves to improve health through better technology, education and market access. Our goal is to minimize doubt and maximize the confidence our customers and their patients have in their decisions and diagnoses.

We work toward this goal every day, always aware that in an increasingly complex and competitive global environment, we must continually earn the trust of our customers and their patients. By focusing on women’s health while still delivering health benefits to everyone, we are setting a new standard of excellence that is strengthened by purpose, driven by passion and brought to life by our promise of more certain early detection and better health outcomes.

To view our community guidelines, visit: www.hologic.com/social-media

Industry
Manufacturing & Production
Company Size
5,001-10,000 employees
Headquarters
Marlborough, MA
Year Founded
1985
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