Quality control/miljømonitorering - Laborant/teknikker til QC Microbiologi

(English version see below)

Har du lyst til at arbejde i et international og inspirerende miljø?

Vi søger en laborant/teknikker vikar for 1 år fra jan. 2023

I AGC Biologics A/S (AGC), arbejder vi med udvikling af biopharmaceutiske produktions processer og GMP produktion af biopharmaceutiske proteiner til både kliniske test og kommercielt salg. Da vi er en kontrakt produktion organisation, er et højt niveau af service til vores kunder i fokus.

Afdelingen

Quality Control i AGC A/S består af flere afdelinger, inkl QC Microbiology (med 15 dedikererede teknikkere/laboranter, 8 scientists og 3 ledere). QC Microbiology er ansvarlig for miljømonitorering (EM) af produktionsområderne, kemiske/mikrobiologiske analyser af pharmaceutisk vand, og TOC analyser af rengøringsprøver fra produktionsudstyr. Derudover mikrobiologiske metode valideringer, analyse af produktionsprøver både til kliniske forsøg og kommerciel produktion af drug substans. QC Microbiologi er i tæt samarbejde med Manufacturing, Up- & Downstream Development, Quality Assurance og eksterne laboratorier med til at supportere alle trin i en produktionsproces. Alt hvad vi gør er i tæt samarbejde med vores kunder.

Opgaver og Ansvar

Som Laborant/teknikker i QC Mikrobiologi vil du skulle tage miljømonitoreringsprøver (EM og vand) samt analyserer disse prøver, derudover også assistere i administrative opgaver f.eks. review af EM data. Ved miljømonitorering og mikrobielle test af produkterne hjælper du med at sikre opretholdelse af de krav til miljøet i vores rene rum, og at de fremstillede produkter er af den forventede mikrobiologiske kvalitet.
Du vil få muligheder for, at foretage undersøgelser/support og lave opfølgninger til korrigerende/ forebyggende aktioner i forbindelse med mikrobielle miljø- og produkt-overskridelser, dette i samarbejde med udviklings- og produktionsafdelinger.

Din Profil

Vi forventer du har en laborant uddannelse eller tilsvarende og måske nogen erhvervserfaring inden for Mikrobiologi/miljømonitorering gerne fra en kvalitetsafdeling/pharmaceutisk industri. Derudover er det en fordel med:

• Erfaring med farmaceutiske mikrobiologiske analyser
• Erfaring med miljømonitering i klassificerede områder
• Høj kvalitetssans og erfaring med review af data
• En god sans for humor og evnen til at planlægge og afslutte dit arbejde selvstændigt og effektivt til tiden i den rette kvalitet
• Erfaring med at arbejde under cGMP
• Evne for at interagere positivt i et team og i tæt samarbejde med andre Laboranter og Scientists
• Evne for at kommunikere professionelt både skriftligt og mundtligt på dansk og engelsk

AGC tilbyder

AGC tilbyder en dynamisk arbejdsplads med gode muligheder for, at arbejde med mange forskellige opgaver og udfordringer. Du vil få indsigt i og erfaring med de forskellige måder afdelinger i en kontraktproduktionsorganisation arbejder sammen for at opnå succes.

Spændende og udfordrende opgaver vil konstant tilgå Quality Control, og du vil i nogen grad selv kunne være med til at planlægge dit daglige arbejde. AGC tilbyder et uformelt arbejdsmiljø, hvor humor er en del af det daglige arbejdsliv. Vi respekterer hinanden og hinandens forskelligheder. AGC Biologics ansatte har en fleksibel attitude og vi hjælper hinanden for at nå deadlines sammen som et team

Send din ansøgning så snart som muligt og senest den 1. dec. 2022. Vi behandler ansøgningerne som vi modtager dem, og kvalificerede ansøger kan forvente at blive indkaldt til samtale før deadline.

For mere information angående stillingen, kontakt Teamleder for teknikkerne i QC Microbiology, Allen Nyendi, telephone +45 2294 3061. Du er velkommen til at sende ansøgning og CV på dansk eller engelsk.

---- English version ----

Laboratory Technician for QC Microbiology/Environmental monitoring in our Quality Control Department

Do you want to work in an international and inspiring environment?

We are looking for a laboratory assistant/technician temporary 1 year from January 2023.

The Department

The Quality Control unit at AGC Biologics A/S consist of several department incl. QC Microbiology (consisting of 15 highly dedicated technicians, 8 scientists and 3 leaders/managers). QC Microbiology is responsible for microbiological analysis on APIs for clinical and commercial samples, method validation, environmental monitoring in clean rooms, sampling and chemical/microbiological analyses on pharmaceutical water, and TOC analysis on rinse samples from production. The work is conducted under cGMP and AGC Biologics handle exciting customer projects from Phase I to Commercial stages.

The department works in close collaboration with Manufacturing, QA, Up- and Downstream Development and external laboratories to maintain control of all steps in the manufacturing processes. Everything we do, we do in close collaboration with our customers.

Tasks and Responsibilities

Your tasks will be environmental sampling incl. analyzing the samples further analyzing product in-process samples. Further also assist in administrative jobs e.g. review of data to EM reports.

Through testing and monitoring, you will help ensure maintenance of the required levels for environmental cleanliness in our clean rooms and that the manufactured products are of the expected microbiological quality and suitable for the intended purposes. You will have the opportunity to do investigations/support and follow-up on corrective/preventive actions in co-operation with Development and Manufacturing departments.

Your Profile

We expect you to hold a degree as laboratory technician or similar and preferably have some experience within the pharmaceutical industry. In addition, you might have some of the following experience and characteristics:

• Experience with pharmaceutical microbiological analyses and water testing
• Knowledge of environmental monitoring of clean rooms
• Experience with working cGMP
• Have a high Quality mindset
• Experience within review of data
• A flexible, dynamic and excellent team player with good English and Danish skills
• A good sense of humor and the ability to plan and complete your work independently and efficiently
• Taking responsibility for your personal assignments and completing high quality work in a timely manner

AGC offers

AGC offers a dynamic working place with good opportunities of working with a varied array of tasks and challenges. You will get insight into and experience the way the various departments throughout a Contract Manufacturing Organization interact in order to achieve success. Exciting and challenging assignments will constantly come your way, and you will to some extend be able to plan your daily work yourself or together with the team. AGC offers an informal working environment, where humor is part of the daily work life. We respect each other and our individual differences. AGC’s employees have a flexible attitude and we help each other to reach deadlines together as one team.

For further information regarding the position, please do not hesitate to contact team leader for technicians in QC Microbiology Allen Nyendi, telephone +45 2294 3061.

We will process the applications as they arrive. Therefore, please submit your application and CV as soon as possible and no later than December 1. 2022. You are welcome to submit either an English or Danish written applications and CV.

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AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.

Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.