Microbiology Analyst
Leiden (NL) | 40 uur
From discovery and development through manufacturing and beyond, at HALIX you experience the full journey!
To support us in our steady growth, we are welcoming a Microbiology Analyst!
The Microbiology Analyst oversees the testing of raw materials, intermediates, and finished products to guarantee their quality. They also conduct environmental monitoring of water systems and clean rooms. You are capable of independently identifying substances and fulfilling all necessary administrative duties for product and raw material approval. Also sampling and verification of raw materials and supplies that are purchased for pharmaceutical processes and / or laboratory activities is part of your job.
Your tasks
- Conducting microbiological analysis according to GMP/GcLP guidelines.
- Performing routine microbiological analyses, including: sterility testing, bioburden, endotoxin and 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 cataloguing and generating stock of facilities resident microflora
- Ensuring correct handling of pathogenic micro-organisms.
- Administrative processing of results and regulations.
- Management of house isolate strains.
- Writing and working on changes and deviations (including OOS).
- Coordinate the verification of raw materials and monitor the lead time of the release process.
- Sampling raw materials under GMP regime.
- Conducting entrance examinations, including certificate checks against the Ph. Eur guidelines.
You have
- 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.
- Advanced knowledge of cGMPs, safety, proper documentation and data-integrity.
- Good command of the Dutch and English language, both verbally as in writing.
Who are we looking for?
Our new colleague has a cooperative mindset, easily adjusts to changes, and demonstrates strong analytical abilities. You excel both independently and within project teams, always striving to deliver impactful results.
Our offer
- You will be part of a steadily growing and dynamic biopharmaceutical company offering a great environment for self-starters.
- A culture that is characterized by entrepreneurial spirit and close and transparent communication. The patient’s well-being is always our top priority. This combination is the basis for an interesting and challenging environment.
- You will be working in our dynamic headquarters in Leiden.
- Being part of a company that is focused on excellence in GMP Manufacturing.
- A competitive salary that matches your responsibilities and experience.
Your application
We look forward to hearing from you! We are interested in your CV, but we also want to find out more about your ambitions, your personality and what drives you to apply. So be sure to include a brief cover letter telling us why you are a match for this position. The application process consists of an introduction by the Recruiter, two interviews either via video call or live at our office in Leiden with the Hiring Manager and/or a Department Specialist followed by contract negotiations. Depending on the vacancy, an assessment could be part of the process.
Important notice to search firms and recruitment agencies
HALIX does not accept unsolicited approaches from recruitment agencies and/or search firms (such as, for instance, the sending of resumes) for any job posted on this or a referring website. All recruitment agencies and search firms are required to contact HALIX Recruitment via recruitment@hal-allergy.com to enquire about a potential recruitment or search agreement with HALIX.
HALIX, Bioscience as a Service
HALIX is a fast growing, biopharmaceutical contract development and manufacturing organization (CDMO) focused on viral vector and recombinant protein products. We support our customers with the development & commercialization of biologics enabling the treatment & prevention of life threatening conditions such as cancer, COVID-19, influenza and other infectious diseases. Our state of the art GMP manufacturing facilities and our experienced and dedicated team of people ensures manufacturing capabilities which meet the highest quality standards, a service oriented way of working and a flexible mindset. If you too would like to become part of an innovative and challenging contract development and manufacturing organization (CDMO), then this is a perfect opportunity!
HALIX is headquartered in Leiden, where all disciplines work under one roof, from development to sales. We work in an informal, culturally diverse organization with room for growth and continued personal development. HALIX is located in the middle of the thriving and energetic Leiden Bio Science Park, the largest innovation district of the Netherlands in the field of Life Sciences & Health. The central train station and the ancient city center of Leiden are just a 5 minute bike ride away from our office.
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