Contract type: Contract
Start Date: Sepember
Location: Luzern
Workload: 100%
Duration: 7 months
Your mission:
* Execute all the Microbiology related testing activities at the large scale manufacturing facility.
* Microbiological identification, bacterial endotoxin test (KCA and KTA), detection of microorganisms (BacT/Alert), growth promotion test and microbial enumeration test.
* Contribute to the development and execution of QC Microbiology related supporting studies.
* Support all activities to ensure that the instrumentation in WIP labs is prepared for each corresponding unit operation to be performed in manufacturing.
* Support the QC Microbiology team with day-to-day analytical operations including test execution and review activities of routine EM and UM samples, as well as MFG support samples (e.g. Cleaning samples) and in-process and drug-substance samples.
* Author and review of GMP documentation (protocols, procedures, CAPAs, deviations, etc.).
* Become a technical expert for classical and rapid methods, supporting the Microbiology Team, and participating in cross-functional activities.
Your background:
* The ideal candidate has background in microbiological analytical methods, works with cGMP-regulated computerized systems, aims to establish a paperless lab, and has experience within Biological Quality Control, Microbiology and analytical function.
* At least 1 year of experience of experience in pharmaceutical or biotech manufacturing environment (MANDATORY).
* At least 1 year of experience in GMP environment (MANDATORY).
* Apprenticeship degree (Laborant EFZ) in Biology or related Life Science or Technical discipline.
* Analytical skills in Microbiology (Bioburden and endotoxin testing, Growth promotion test, etc...).
* Must have a working understanding of modern analytical microbiological modalities to facilitate the execution of analytical quality strategies.
* Demonstrated problem solving skills.
* Demonstrated ability to work autonomously and cross-functionally.
* Strong presentation and organizational skills.
* Must have strong technical skills and be proficient with typical productivity software (Word, Excel, Power Point, Visio, etc.).
* Must have proficiencies with the Quality systems and business processes associated with Microbiology testing (drug substance).
* English (minimum level B1).
What's on offer
* A seven-month contract at an internationally known biotechnology company.
* A competitive salary.
If this sounds like you, don't hesitate to apply here or reach out directly to Hugo Palejowski, Recruiter: Write an email.
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https://www.swisslinx.com/job/16113en
