Microbiology Analyst at HAL Allergy

The analyst microbiology is responsible for conducting tests on samples of raw materials, intermediates, endproducts for release and environmental monitoring of water systems and clean rooms. The analyst is able to independently execute identifications. In addition, he/she performs all administrative actions that are necessary for the approval of products and raw materials.

Responsabilities:

  • Conducting microbiological analysis according to GMP/GcLP guidelines
  • Preforming routine microbiological analyses, including - sterility testing - bioburden - endotoxin - growth promotion testing
  • Environmental monitoring of cleanrooms and water systems
  • Execution of the sterility tests
  • (Independent) assessment of the result obtained, in case of deviations, report this to the microbiology manager or deputy
  • Assist in the tracking, trending, and identification of all facility micro-organisms including cataloging and generating stock of facilities resident microfloraEnsuring correct handling of pathogenic micro-orga
  • Administrative processing of results and regulations
  • Management of house isolate strains
  • Writing and working on changes and deviations (including OOS).

Requirements:

  • Minimum MBO/HBO degree Microbiology
  • A minimum of 2 years of experience in the pharmaceutical and/or biotech industry in sampling and testing of critical utilities and environmental monitoring within a GMP environment
  • Qualified to work in a Class A / B cleanroom
  • Extensive experience in performing testing such as environmental monitoring, bioburden, growth promotion and  endotoxin

Skills:

  • Professional self-development
  • Result and quality oriented
  • Accountability
  • Cooperation
  • Advanced knowledge of cGMPs, safety, proper documentation and data-integrity
  • Strong communication skills
  • Knowledge of the Dutch and English language spoken and written

Find out more about drug development at Leiden Bio Science Park.

R&D