This is an exciting opportunity for a motivated individual with a solid foundation in microbiology and experience in GMP-regulated environments to grow their career while working in our client's state-of-the-art facility on an initial 12 months contract. You will contribute to vital cleanroom and utility monitoring, in-process testing, and microbiological analysis that directly supports manufacturing operations. If you’re looking to make a meaningful impact in the biopharmaceutical industry while advancing your technical skills, we’d love to hear from you.
Key Responsibilities
· Perform cleanroom, BSC & Isolator batch related monitoring.
· Utility sampling of water systems and Compressed Air/Gas.
· Carrying out In-Process testing of critical lot related samples to support Manufacturing activities (HPLC and UV Spectrophotometry).
· Issuance, receipt, and testing of biological indicators.
· Reading and reporting of environmental monitoring, BIs, and aseptic qualification sample results.
· Reconciliation and inspection of media fill units, and participation in media fills.
· Carrying out identifications of Microorganisms isolated post testing activities.
· Completing all laboratory documentation in a timely and accurate manner.
· Compliance with Standard Operating Procedures and Registered Specifications.
· Assisting in authoring and reviewing documentation.
· Providing support to other departments to ensure qualification and production schedules are adhered to.
· Reviewing paperwork, and reconciliation of analysis performed in the laboratory.
· Ensuring that any alert/action limit excursions are investigated according to site procedures.
· Receipt and processing of drug substance and drug product samples.
· Adherence to and improvement upon lean lab and 6S practices.
· Ensuring a high standard of housekeeping and safety is maintained in the laboratory.
· Performing any other activities as indicated by the Microbiology Manager.
Qualification and Experience
· The ideal candidate should hold a minimum of a Level 8 degree in Microbiology or related discipline.
· At least 2 years’ experience in a pharmaceutical / healthcare laboratory or related technical function.
· Applicants should have relevant experience working in a cleanroom environment using aseptic techniques, and experience working with isolators is advantageous.
· Experience in HPLC and UV Spectrophotometry is desirable but not essential.
· Experience using MODA, Empower, CIMS, LIMS, LES and Veeva Vault is desirable but not essential.
· The successful candidate must demonstrate excellent written and verbal communication skills.
· The ability to work in a team based collaborative environment is essential.
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