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Regulatory Affairs Specialist

The RA Specialist for Radiometer is responsible for ensuring coordination of regulatory activities for a few of our Blood Gas products manufactured in California to help ensure continued compliance in all markets.

In this role, you will have the opportunity to:

• Facilitate coordination of regulatory activities between California and Denmark for design control activities and international registrations for a few of the instruments/consumables manufactured in our California site.
• Ensure compliance with EU regulations.
• Generate STED files, international submissions & assess design changes.
• Plan and execute projects for new regulatory requirements.

Procesingeniør

Har du lyst til at starte din karriere med at arbejde inden for farmaceutisk produktion? Og har du mod på at bevæge dig ud i tværfaglige udfordringer, der ligger lidt uden for din uddannelse?

Vi er en virksomhed i vækst, og produktionsvolumenerne vokser – så derfor har vi et stort behov for at styrke vores ingeniørgruppe med et nyt medlem, der kan medvirke til, at vi får moderniseret vores udstyr, som produktionen vil få stor gavn af.

QC-laborant med varierende opgaver

Har du lyst til at sikre kvaliteten af vores API’er i en QC-funktion, hvor du får lov at løse en palet af forskellige opgaver? Har du lyst til at blive en del af en velfungerende gruppe, hvor du løbende bliver trænet i nye opgaver af dine erfarne kolleger?

Så er det måske dig, der er vores kommende QC-laborant. Vi er i en proces, hvor vi vokser, og derfor søger vi en laborant, der trives med fleksibilitet og gerne vil udvikle sig.

Vi vil altid være lydhøre over for den enkelte laborant. Hvis du har interesse for en opgave, så lytter vi og sørger for, at du bliver trænet i den og får lov til at løse den

Regulatory Affairs Manager

The Regulatory Affairs Manager at Radiometer is responsible for managing the preparation and submission of the required documentation for product registration, approval, and compliance with international regulations.

This role is critical for ensuring that Radiometer's products can be sold in markets around the world. You will have the opportunity to:

• Ensure regulatory compliance to maintain market approvals
• Lead a team of skilled RA associates
• Ensure alignment with relevant stakeholders

Downstream processing engineer – 12 months position

In this position you will be part of River Stone’s downstream processing (DSP) team, which is responsible for developing purification methods for our biological production processes for pharmaceutical ingredients.

The ideal candidate possesses:

• M.Sc. or Ph.D. degree in chemical engineering, food process engineering, chemistry, or similar
• Experience within down-stream purification processes, like solid-liquid separation, membrane filtration, crystallization and/or drying is a requirement
• Flair and motivation for hands-on laboratory work
• Ability to work in a fast-paced environment with deadlines and sometimes limited time for data analysis

QA Engineer – ensure the quality of our software solutions for pharmaceutical drugs and devices

Do you want to play a key role in delivering software systems that are compliant to the pharmaceutical industry?

As Quality Engineer, you will work together with the project manager, the software developers and the customers validation teams and help secure that our solutions are compliant and lives up to the customers expectation so they can re-use our validation as their own.

You are the expert on what makes you happy and efficient. So, whether that entails a 4-day work week or working in the evening or from home that is simply how you will be working.

Vision Engineer – ensure the quality of pharmaceutical drugs and devices

Do you want to play a key role in delivering vision inspection solutions for advanced production machines?

As Vision Engineer, you will implement inspection solutions that improve patient safety by ensuring the quality of pharmaceutical products and devices.

You are the expert on what makes you happy and efficient. So, whether that entails a 4-day work week or working in the evening or from home that is simply how you will be working.

Erfaren akademiker til procesforbedringer

Vil du være med til at bekæmpe kræft? Brænder du for at lave forbedringer? Er du klar til at gøre en forskel for dine kolleger og forbedre produktionsfaciliteterne til gavn for Agilents kunder?

Stillingen er i Filling And Packaging (FAP), der er en del af produktionen i Agilent, Glostrup. FAP har to producerende afdelinger (Filling og Packaging) med i alt 25 operatører og et supportteam på 7 produktionssupportere. Vi fokuserer på at levere diagnostiske produkter af høj kvalitet til vores kunder. Du bliver en del af vores team af produktionssupportere, der skal understøtte og optimere produktionen i Filling og Packaging.

Quality Assurance Specialist

Would you like to be part of a strong and very skilled QA team supporting the qualification of GxP manufacturing equipment, facilities and utility systems?

You will be part of a well-founded team with 8 colleagues (4 Equipment qualification + 4 Environment) for Equipment qualification in QA Operations reporting to the QA Ops Manager for Qualification and Environment.

Facility & Utility Engineer med fokus på løbende forbedringer

Brænder du for at sikre den daglige drift og vedligeholdelse inden for facility & utility? Trives du med at koordinere og dagligt være i kontakt med eksterne håndværkere? Kan du lide at planlægge, koordinere og strukturere vedligehold af tekniske installationer og bygninger?

Til denne spændende stilling vil du indgå i en PMO og Utility/Facility afdeling, hvor opgaverne er mange og alsidige. Du vil få den daglige sparring med ingeniører og teknikere i produktionsenheden i Horsens. Du vil varetage en lang række opgaver inden for optimeringsprojekter, og sikre at Facility og Utillity installationerne til stadighed opfylder kravene.

Manufacturing Science & Technology (MS&T) Technical Transfer Project Manager (Sr Specialist)

Join Orifarm and take charge of building strong business relationships with a key portfolio of our suppliers!

As a MS&T Technical Transfer Project Manager, you will be responsible for securing technical support to Supplier Relationship Management functions, and manufacturing sites comprising support, technological transfers between CMOs and own manufacturing sites, analytical method development and validation, external product development at CDMOs and driving continuous technological improvement and innovation.

Laborant til Incoming QC

Vil du bidrage til diagnostik af cancer og gøre en forskel for patienter? Er du detaljeorienteret og lægger vægt på korrekt produktion og dokumentation? Trives du i et spændende produktionsmiljø?

I Incoming Quality Control (IQC) foretager vi kvalitetskontrol af råvarer og Outsourced supplier materials, hvor vi sikrer at den korrekte dokumentation er tilstede, før vi godkender råvarerne til produktion. Desuden foretager vi test af nogle råvarer, ELISA tests, Bioburden og analyser af vandprøver.

Hverdagen består hovedsageligt af grundig kvalitetskontrol af dokumentation og reviews samt laboratoriearbejde, men vi prioriterer også tid til løbende forbedringer af vores arbejdsgange og processer.

Make a difference for people, customers, and the planet by transforming and upgrading the factory

Are you equipped with solid project management skills?

You will play a central role in driving their improvement and optimizing projects on existing equipment and also expanding with new production equipment and methods.

You will become part of a dynamic team driven by a shared vision of innovation and sustainability.

Your work and projects will contribute to, and be an essential part in, achieving Alfa Laval’s ambitious goal: To become carbon neutral in 2030.