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Senior Biotechnology Specialist

2 weeks ago

Sligo, Sligo, Ireland beBeeMicrobiologist Full time

Job Overview

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We are seeking a highly skilled Microbiologist to join our team in Ballytivnan. This individual will provide expert microbiological and analytical services to our sterile biologics facility, ensuring that all microbiological procedures and requirements are met.

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The successful candidate will be responsible for implementing the facilities sterility assurance program and providing microbiological support activities, including facility design, filling of sterile product, and aseptic practices.

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This role requires a strong understanding of aseptic and sterile processes, as well as experience within a GMP environment and knowledge of current EU/FDA/ICH/HPRA and Annex 1 guidelines.

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A Bachelor's Degree qualification in biology or microbiology is required, along with a minimum of 3-5 years' experience in microbiology. Working in a sterile/aseptic/pharma environment is an advantage.

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The ideal candidate will have experience in supporting regulatory inspections and cleaning validation.

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Responsibilities

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  • Implement the facilities sterility assurance program and provide microbiological support activities.">
  • Lead and implement microbiological and analytical services to meet and maintain all requirements for aseptic processing, facility design, and filling of sterile product.">
  • Provide microbiological/sterility assurance/technical governance of in-process and finished product per product requirements.">
  • Understand regulations and business processes required to maintain AbbVie's and cGMP requirements for sterile product, inclusive of facility design, cross-contamination controls, microbiological laboratory standards, and data integrity.">
  • Define and update procedures for site relative to microbiological and environmental monitoring.">
  • Interface with regulatory and corporate inspectors/auditors.">
  • Carry out training as per training plan to support facility sterility assurance program.">
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Requirements

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Education and Qualifications:

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Bachelor Degree qualification in biology or microbiology.

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Experience:

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A minimum of 3-5 years' experience in microbiology.

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Skills and Knowledge:

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A thorough knowledge of aseptic and sterile processes together with experience within a GMP environment and knowledge of current EU/FDA/ICH/HPRA and Annex 1 guidelines.

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Additional Requirements:

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Working in a sterile/aseptic/pharma environment is an advantage.

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Experience in supporting regulatory inspections HPRA, FDA etc. is an advantage.

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Experience in cleaning validation is an advantage.

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