Environment Monitoring (QC) Technician

For the English version, please see below.

Environment Monitoring Technician

Ben je net aan je carrière begonnen en heb je een passie voor kwaliteitscontrole en microbiologie? En wil jij werken in een innovatieve werkomgeving waar jij het verschil kunt maken, dan is dit de juiste kans voor jou!

We zijn op zoek naar een Environment Monitoring (EM) Technician Quality Control om ons team te versterken in onze state-of-the-art GMP-faciliteit voor nieuwe gen- en celtherapieën.

Wat ga je doen

Als EM Technician Quality Control ben je verantwoordelijk voor het waarborgen van de kwaliteit van onze gen- en celtherapieproducten en de omgeving van onze GMP faciliteit door te werken volgens de NecstGen procedures. Je belangrijkste focus zal liggen op het uitvoeren van environmental monitoring in onze verschillende cleanrooms, waarbij je voldoet aan onze vereisten voor aseptische handeling en omkleding. Daarnaast ondersteun je de afdeling door kwaliteitstesten uit te voeren, inkomende goederen te testen, GMP monsters te ontvangen, gegevens te analyseren en resultaten te rapporteren. Alle taken worden uitgevoerd in overeenstemming met de GMP-normen.

Taken en Verantwoordelijkheden

• Voorbereiden en nemen van omgevingsmonsters in een GMP omgeving (luchtreinheid bepalen op basis van deeltjesconcentratie en/of contaminatie van levende micro-organisme) inclusief het bijhouden van gegevens en rapportage;

• Het ondersteunen en uitvoeren van microbiologische testen, zoals; Kiemgetal bepalen, Gram-kleuring, bioburden, groeipromotie;

• Kwaliteitscontrole activiteiten, zoals analyseren en testen van inkomende goede producten;

• Laboratoriumondersteuning bieden door taken uit te voeren zoals onderhoud en kalibratie van apparatuur, voorbereiding van monsters en reagents, documentbeheer, etc;

• Voldoen aan GMP & veiligheidsnormen;

• Continu verbeteren van mogelijkheden en het bijhouden van GMP trainingen.

Environment Monitoring Technician

Are you just starting your career and do you have a passion for QC ? Do you want to work in an innovative working environment where you can make a difference, this is the right opportunity for you! 
We are looking for an Environment Monitoring (EM) Technician to join us in a state-of-the-art GMP facility for novel gene and cell therapies. This is your chance to become part of our organisation with the mission to enable early stage researchers and Subject Matter Experts to bring their novel gene or cell therapy into the clinic.

What you will do

As EM Technician you are responsible for ensuring the quality of our gene and cell therapy products by working according to NecstGen procedures. Your main focus will be to perform environmental monitoring of our cleanroom facilities, while adhering to our aseptic gowning requirements. You may also support the QC department by performing QC assays, incoming good testing, receiving samples, data analysis and reporting results. All tasks will be performed while adhering to GMP standards.

You will:

• Prepare and execute environmental monitoring, including trending of data and reporting;
• Also support other QC activities e.g. assays and incoming good testing etc.;
• Provide general laboratory support by performing tasks such as equipment maintenance and calibration, preparation of samples and reagents, document management etc. when required;
• Adhere to GMP & safety standards;
• Continuously improve capabilities and keep training status up-to-date.

What we ask

We are looking for a EM Technician with:

• MBO degree in a relevant field (microbiology or comparable) and/or relevant work experience;
• Written and verbal communication skills in English. Dutch is desirable;
• Experience with microbial techniques such as endotoxin, bioburden and sterility tests will be an advantage but not required;
• Experience in cleanroom facilities, working with GMP and LIMS is a plus but not required;
• A pro-active attitude, able to work independently as well as in a team, flexible, organized;
• Minimum of 1 year of relevant work experience (including relevant internships);
• Good record-keeping skills.

What we offer

It is important that you are comfortable at work and enjoy coming to the office. We offer a modern and inspiring working environment with a collegial atmosphere, a flat organization with short lines and good employment conditions:

• A competitive salary
• 8% holiday allowance
• Permanent 13^th month
• 25 holidays with a fulltime employment of 36 hours per week
• Commuting allowance (from 10 km) of € 0,23 per km and public transport is fully reimbursed
• A non-contributory pension scheme
• Several flexible employment conditions on top of the above conditions
• Exciting dynamics of a scale-up environment and GMP training by our expert team

About NecstGen

Together with our clients and partners we challenge today’s possibilities and enable the unthinkable.

NecstGen primarily works with early-stage research organisations, start-ups, and SMEs to develop efficient processes and perform GMP manufacturing for cell and gene therapies. We engage openly with organisations worldwide! NecstGen is a subsidiary corporation of the Leiden University Medical Center. Our unique company formation enables us to be a mission based CDMO and Centre of Excellence. NecstGen’s 4,000+m² facility comprises of 13 cleanrooms plus development and Quality Control laboratories for the generation of novel therapeutics. Our team of 40 consists of professionals from industry and academia with an entrepreneurial mindset and a drive to make a difference. We have a flat organisational structure with a participative management style.
Visit our LinkedIn company page to learn more about our team and the latest developments.

We would love to hear from you!

Don’t hesitate to contact Warda Cardozo, Head of HR for more information.

Unfortunately, sponsorships for Non-EU citizens are not available. 

We do not wish to be approached as a potential customer or client.