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Sterility Assurance Specialist (Microbiologist)

Req ID: J2298602

  • Ubicación
    Monumento, CO, Colorado, United States of America
  • Categoría Investigacion & Desarrollo
  • Publicado jueves, 13 de enero de 2022
  • Tipo Tiempo completo
  • Tipo de Empleo Empleado Permanente

Descripción del Trabajo

OVERALL RESPONSIBILITIES:

The Microbiologist will be responsible for the implementation and support of Environmental Monitoring (EM) and contamination control at the Manufacturing site in compliance with US FDA (QSR) regulations, Canadian Medical Device Regulation (CMDR), Medical Device Directive (MDD), ISO 13485, ISO 14971 and ISO 9001.

Quality control experience needed; experience with non-conformances, CAPAs, change controls, OOS investigations drafting reports, procedures, test methods - technical writing

POSITION DUTIES & RESPONSIBILITIES:

Provide biological and chemical testing oversight to ensure the adequacy of these activities and documentation in terms of regulatory compliance and technical soundness at the manufacturing facilities. 

Work closely with the Manufacturing and Quality groups to establish and maintain procedures, tools and methodologies related to the EM and product testing programs. 

Maintain knowledge of FDA and ISO EM guidelines, as applicable.

Implement and responsibly execute routine sterilization and microbiological programs.

Conduct technical assessments of contract laboratories. 

Provide guidance and training to personnel to ensure biological and chemical program requirements are met.

Provide input on design of manufacturing processes, controlled environments and finishing, including cleaning, to ensure their efficacy for obtaining clean and safe products. 

Provide input on design of cleanrooms and systems to generate processed water and compressed air. 

Support validation of process water, compressed air, controlled environments and finishing processes.

Provide guidance to plant personnel, as required, ensuring good manufacturing and good documentation practices. 

Know and follow all laws and policies that apply to the position, and maintain the highest levels of professionalism, ethics and compliance at all times. 

Diligently participate in compliance program-related activities.

Other duties/responsibilities as assigned by manager.  

EDUCATION & EXPERIENCE REQUIREMENTS:

A minimum of a Bachelor's degree (focus on Microbiology, Biological Science, or Engineering is preferred) and 3 years of microbiological experience; or an advance degree (M.S., PhD) and 1 year of microbiological experience.  Industry experience in medical device and / or pharmaceutical is highly preferred.  Experience working in a GMP-regulated environment is required.  Experience with sterilization processes, microbiological testing, and water testing is strongly preferred.  Environmental monitoring, testing, and investigational experience is required. 

Strong knowledge in government regulations and industry guidelines for environmental monitoring (e.g. ISO/EN/AAMI) and knowledge/familiarity in microbiological control of medical devices is preferred. 

Taking a highly collaborative approach with ability to work independently and in a highly professional manner is required.  Excellent communication/time-management skills are required.  Proficiency in Microsoft Power Point, Word, Excel, and standard experimental analysis software is required. 

PROFESSIONAL EXPERIENCE REQUIREMENTS:

  • Strict attention to detail.
  • Must be able to work in an open office environment.
  • Must be able to work under pressure due to reporting deadlines.
  • Must be able to work independently and prioritize with minimal supervision.
  • Strong written and oral communication, organization, and time-managements skills are required.
  • Experience working in a GMP-regulated environment is required. 
  • Minimum of one year of environmental monitoring, testing, and investigational experience is required.

OTHER REQUIREMENTS:

  • Excellent knowledge of English language
  • Basic understanding of chemistry and microbiology.

The anticipated pay range for this role is $52,888 - $76,600 - $100,422. Job-related, non-discriminatory factors used to determine the actual offered rate include qualifications and experience, geographic location, education, external market data, and consideration of internal equity.

As part of the total rewards package, this position is eligible for a short-term incentive based on performance. In addition, Jabil offers benefits to enhance your health, wealth and resilient self. These include medical, dental, and vision insurance plans; 401(k) retirement plan and employee stock purpose plan; and paid time off.

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