Job description

YOU will be responsible for supporting the establishment, validation, qualification & ongoing support of pharmaceutical cleanroom and all associates test programs.

YOU will provide microbiological support in the establishment of the Contamination Control Strategy & ongoing support to Operations, in ensuring operational goals & objectives are achieved for the plant.

This role plays a key part in establishing, maintaining & enhancing the Microbiological monitoring programs developed to ensure the sterility assurance of the product.

Job Responsibilities

  • Review and approve microbiological procedures, protocols, and reports. Support validation & engineering qualification activities.
  • Provide support & technical expertise to ensure best practices.
  • Support the development of the site strategy for cleanroom behaviors, aseptic practices & training of personnel.
  • Lead and provide direction in all areas relating to the sterility assurance of the product.
  • Microbiological systems & associated documents management.
  • Provide expertise to other functions on quality-related issues e.g regulatory requirements, sampling principles etc.
  • Evaluate quality events ensuring compliance with cGMP & quality standard requirements. Ensure timely & effective actions are implemented & CAPA effectiveness checks are conducted.

Job Requirements

  • Level 8 in Microbiology or a related discipline
  • 3+ years’ experience within a pharmaceutical GMP environment, ideally within a Microbiological function.
  • Working knowledge of FDA, HPRA & pharmaceutical industry microbiological requirements & associated manufacturing controls is desirable.
  • Experience in problem-solving & process improvements is desirable.
  • CAPA experience, Risk Management & Process Validation is also desirable.

For a confidential discussion on this or any other current job opportunity please contact Meggan on 021 235 9144 /

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.