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Senior Specialist Clinical Safety and Pharmacovigilance (CSPV)

At Bavarian Nordic, we aspire to save and improve lives by developing innovative vaccines that are designed to unlock the power of the immune system.

The global team consists of subject matter experts for vaccine safety who work either from our site or remotely in Denmark and globally. Together they constantly collect and assess data for the life cycle benefit risk management across our vaccines whether authorized or still in clinical development.

You would add your clinical safety and pharmacovigilance expertise as your depth knowledge of the PV legislation to the team.

Laborant QC Sampleflow

Har du laboratorieerfaring og kunne du tænke dig at tage det næste skridt i din karriere?

Du får ansvar for og stor medbestemmelse over dine opgaver så de fleste dage vil gå stærkt, og opgaverne bliver ofte andre end dem, du havde planlagt og forventet.

Du vil opleve en dynamisk og udfordrende hverdag i QC, med mange spændende opgaver og en åbenhed over for nye idéer.

Project Manager

Do you have experience in driving technical projects and want to be part of a company on an exciting growth track?

You will contribute to projects ranging from new equipment lines to the replacement of existing equipment and systems. As a Project Manager, you will lead projects or be responsible for and execute work packages or tracks, depending on project size.

Project Coordinator

Do you have experience managing projects anchored to a GMP facility? Are you eager to contribute to the development of a newly established project team in a production environment?

As a Project Coordinator, you will participate in the successful planning and completion of projects related to the Drug Substance Manufacturing Processes. You will coordinate and follow up on a number of tracks that links to various projects.

Operators for Drug Product Manufacturing

Would you like to be part of an international pharmaceutical company in rapid growth, which offers good development opportunities and set shifts?

This project is in the early phase of establishment and in the beginning, you will help design and establish processes for the upcoming production.

Main tasks:

• Participate in running and validation of equipment on site
• Assist during installation of equipment on site and carry out qualification tests afterwards

Operations Data Coordinator for Drug Substance Production

The primary task within the position is to collaborate with various departments (e.g., automation, tech transfer, and manufacturing departments) to collect and translate information required for building efficient production campaigns and daily task schedules.

You will be part of a team with a great sense of humor and a high willingness to support where needed.

QA Specialist for Environmental Support

In this role, you will join Bavarian Nordic's QA Organization as a QA Specialist tasked with establishing strong relationships with stakeholders, effectively communicating GxP requirements, and handling crucial Quality Events in the Quality Management System (QMS).

This is in the context of environmental monitoring, aseptic performance, and sterile & low bioburden processes in Drug Substance and Drug Product Production. Additionally, you will contribute to the ongoing improvement of QA processes to elevate overall quality standards.

Manufacturing Support Documentation Associate

Do you have a flair for compliance and can handle many stakeholders? Are you looking for a position where you can take on responsibility?

About the position:

• Create and maintain records and procedures by collecting information from stakeholders to supply manufacturing with compliant documents.
• Start-up events and support investigations by giving input as procedural SME.
• Support the change process by writing SME assessment to ensure procedural alignment. Perform timely closure of action items to ensure reliable execution of production.
• Continuously improve the department processes and support stakeholder improvement projects.

Microbiologist

You will contribute to the testing and release of vaccines against critical diseases. QC Microbiology is responsible for performing analyzes of routine samples and validations of new products.

You will be part of a workplace with a high pace and many different types of tasks e.g.: Approval of sample results, write deviations and change requests, and write validation protocols and reports.

Ingeniør til kvalificering og validering til Croda

Vil du være en del af et fantastisk team, der dækker alle processer, der er nødvendige for aseptisk produktion af adjuvanser og kunne du tænke dig at arbejde med kvalificering og validering så har vi et spændende job.

Du vil indgå i teamet, som består af processpecialister, produktionssupportere og valideringsspecialister, hvor du vil få ansvar for vores kvalificering og validering.

Senior Global Desktop Engineer

We are looking for an experienced, passioned and service minded Sr. Global Desktop Engineer II to join the Global Desktop Engineering team.

Your primary tasks will be:

• Provides technical support to customers on standard operation of core systems
• Responsible for monitoring, managing, and troubleshooting an organization's end user computing across the FDB

You will be surrounded by highly dedicated and skilled colleagues across the globe who all works on the mission of ensuring stable, efficient and compliant IT solutions.

Laborant til Process Development af vaccineproduktionsprocesser

Har du lyst til at være med i udviklingen af vacciner til forebyggelse af infektionssygdomme? Så søg jobbet som laborant her hos os!

Helt kort er opgaverne:

• Udføre analyser af vacciner, såsom HPLC, ELISA, partikelanalyse, DNA og protein-bestemmelse
• Udføre udviklingsstudier i tæt samarbejde med vores scientists såsom procesudvikling, cellulære studier, vaccineformulerings- og stabilitets-studier

Environmental Specialist

I afdelingen for miljø hos Bavarian Nordic er der fuld fart på. De søger derfor en ny kollega, som skal være med til at implementere forbedringsprojekter i produktionen, og det er her du kommer ind i billedet! Som Environmental Specialist skal du sikre, at virksomheden overholder lovgivning og standarder. Herudover foretager du risikovurderinger og udarbejder rapporter.

Din hovedopgave bliver at implementere forbedringsprojekter i produktionen. Du skal identificere områder, der kan forbedres, planlægge og eksekvere implementeringen, og herefter teste og følge op. Du er selv til stede ved test i produktionsområderne.

Environmental Supporter

I afdelingen for Miljø har de det overordnede ansvar for at opretholde og kontrollere renligheden i de aseptiske produktionsområder, hvilket sker i tæt samarbejde med produktionen, QA, teknisk service og øvrige supportafdelinger.Som Environmental Supporter yder du support til både vaccineproduktionen og virksomhedens fyldefabrik.

Din hovedopgave kommer til at bestå i at supporterer virksomhedens procesfolk i den aseptiske produktion. Du kommer til at håndtere de daglige udfordringer i vaccineproduktionen, evaluere data for miljømonitorering af proces og renrum og drive afvigelses- og ændringssager for produktionen.

HVAC Support Specialist

Som HVAC Support Specialist arbejder du med tre produktionsområder med hver deres ventilationssystem, der skal testes hvert halve år. Det er eksterne samarbejdspartnere, der udfører testen, men du er som HVAC Support Specialist ansvarlig for at facilitere processen, afrapportere den samt sikre at compliance overholdes.

Din hovedopgave er at være facilitator for at teste de tre ventilationssystemer. Dette inkluderer udarbejdelsen af protokoller inden tests og efterfølgende afrapportering i diverse rapporter. Testene foregår, når produktionen er lukket ned i henholdsvis en sommer- og en vinterperiode.

Aseptic Specialist

Bavarian Nordic øger kapaciteten, og de har brug for ekstra ressourcer til at sikre de aseptiske processer.

Som Aseptic Proces Specialist er din opgave at sikre de mest kritiske aseptiske processer, hvor der er ”åbent” til den unikke levende virus, og kvalificere den aseptiske proces som produkterne skal igennem.Du bliver ansvarlig for at disse kritiske aseptiske trin efterleves, og der leves op til de strenge sterilitetskrav fra myndighederne.

Du kommer til at være hovedansvarlig for de mest kritiske aseptiske processer, og at aseptiske teknikker og procedurer overholdes i alle faser af vaccineproduktionen.

Single Use Systems Professionals

Som Single Use Systems Professional arbejder du med at forbedre Drug Substance produktionens Single Use systemer. Det kan eks. være i forbindelse med en eksisterende item, der ikke fungerer optimalt eller udgår. Du skal derfor søge efter brugbare erstatninger på markedet og kommunikere med leverandørerne og i samarbejde med processpecialisterne designe nye løsninger.

Du bliver en del af en afdeling på i alt 14 kolleger og i dette team er der 7, hvor alderen ligger omkring 30-45 år. Som ny medarbejder bliver du sidemandsoplært og kommer til at følge interne kurser. Du får også en Buddy fra teamet, som du kan støtte dig til.

GMP-supporter

Som GMP-supporter vil du blive ansvarlig for en række vigtige opgaver inden for produktionens kvalitetsstyring. Dine primære ansvarsområder inkluderer gennemgang af batchdokumentation i overensstemmelse med GMP-standarder og procedurer.

Desuden vil du spille en central rolle i opstart og afslutning af produktionsbatches i Dynamics. Dette indebærer en nøje overvågning af dokumentation fra produktionsprocessen for at sikre, at alle trin udføres i overensstemmelse med gældende procedurer.

Senior Scientist, Infectious Disease Vaccine Discovery and Research

You will conduct various laboratory activities with the primary goal of producing reliable test results and optimizing lab procedures while adhering to correct procedures as well as health and safety guidelines. The role also includes documentation and reporting of results both in writing and in different forums.

You will work with dedicated colleagues in an inspiring and fast-moving environment with a collaborative and innovative spirit.

Column Pack Operator

The work we do at FUJIFILM Diosynth Biotechnologies (FDB) has never been more important—and we are looking for talented candidates to join us. We’re growing our locations, our capabilities, our teams and looking for passionate, mission-driven people who want to make a real difference in people’s lives.

We are currently looking for candidates to work within Drug Substance Manufacturing (DSM) Support and become part of a newly established team, responsible for preparation, packing and qualification of chromatography columns.