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Job Post Details

Company Microbiologist - South Dublin (AM18569) - job post

ICDS Recruitment Consultants
3.5 out of 5 stars
South Dublin, County Dublin
Permanent, Full-time

Job details

Job type

  • Permanent
  • Full-time

Location

South Dublin, County Dublin

Full job description

Company Microbiologist - South Dublin.

In this role you will be accountable for ensuring that all products produced at the site adhere to the specified microbiological and sterilization standards.

Responsibilities:

  • Responsible for maintaining up-to-date knowledge of all current relevant worldwide regulatory requirements that relate to products manufactured at this location
  • Manage daily operations of the in-house microbiology laboratory, ensuring timely and accurate testing and equipment maintenance
  • Setting of appropriate microbiological quality standards for all products, and implementation across the site in compliance with all sterilisation and environmental monitoring requirements
  • Work with cross-functional teams to support the radiation sterilization validation and routine monitoring for all products.
  • Responsible for overseeing, approving and maintaining the Dose establishment, Bioburden testing, sterility testing, endotoxin testing and environmental monitoring programs for the site.
  • Responsible for Risk assessments to support the sterility assurance activities on site.
  • Responsible for determination of sterility assurance requirements for the site change control program.
  • Responsible for all Sterility assurance and microbiology related out of specification investigations, non-conformances and CAPA.
  • Responsible for the sterilization product release program for all products from the site.
  • Act as Microbiology and Sterilization Technical Specialist and SME for the site, and participate in audits to represent the sterility assurance function.
  • Act as an internal auditor supporting the site internal audit program.
  • Integrate and collaborate with appropriate technical specialist groups.
  • Responsible for the validation and maintenance of environmental monitoring programs, and environmentally controlled manufacturing areas for the site.

Interested applicants should have:

  • Degree in Science or a related Quality discipline specialising in Microbiology
  • At least 8 years' experience in a similar role, preferably in a medical devices, pharmaceutical or biologics manufacturing environment, experience supervising personnel and managing projects.
  • Radiation and terminal sterilization experience would be advantageous
  • Excellent interpersonal, communication and team building skills
  • Must be computer literate
  • Experience in process validation, sterilization and working in a cleanroom environment would be advantageous.

Job Types: Full-time, Permanent

Work Location: In person

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