Regulated Manufacturing Expert

About the JobWe are seeking a highly skilled Senior Infrastructure Architect to join our team. You will have extensive experience in GxP-regulated environments and a strong understanding of the Purdue Enterprise Reference Architecture.Your key responsibilities will include designing and implementing infrastructure architecture, ensuring compliance with...

What You'll DoYou will design and implement infrastructure architecture for GxP-regulated environments, ensuring compliance with industry standards such as GAMP.You will also apply Purdue Model principles to align manufacturing IT and automation layers, providing expert guidance on validation, data integrity, and compliance in a regulated...

Are you a skilled Sourcing and Manufacturing Expert looking for a new challenge? We are seeking a talented individual to join our team at Birdie as a Sourcing and Manufacturing Expert. In this role, you will be responsible for taking products from concept to launch, ensuring everything runs smoothly and efficiently.You will work closely with our team to...

About FactbirdFactbird is a cutting-edge SaaS company transforming the manufacturing world with its innovative solutions. Our mission is to make manufacturing smarter, more sustainable, and efficient.We specialize in manufacturing intelligence software and provide cloud-based solutions and plug-and-play hardware for manufacturers looking to up their game....

In this role as an Advanced Contract Manufacturing Expert, you will play a critical part in ensuring the quality and compliance of our Contract Manufacturing Organizations (CMOs) worldwide.As a subject matter expert in quality assurance, you will develop and implement effective QA strategies to ensure adherence to cGMP and Marketing Authorizations. Your...

About UsAt Brinch & Partners, we are dedicated to helping our clients find the best talent in the industry. We work closely with our partners to understand their needs and provide them with top-notch candidates.Ceramic Manufacturing RoleWe are seeking an experienced Ceramic Manufacturing Expert to join our team of professionals. As a key member of our...

We are seeking an experienced Clinical Production Support Expert to join our Clinical Team in Manufacturing Product Support department. As a key member of our team, you will be responsible for providing technical support for clinical production, ensuring compliance with GMP regulations.The ideal candidate has experience working in a cGMP environment and is...

Join our team as a Global Contract Manufacturing Expert and take on the challenge of ensuring the quality of our products manufactured by Contract Manufacturing Organizations (CMOs).About the RoleYou will be responsible for overseeing the quality processes of our CMOs for Active Pharmaceutical Ingredients (API) and Drug Substance (DS). This involves working...

Digital Transformation Opportunities:Systematic is a pioneer in digital transformation, helping Danish manufacturing companies on their Industry 5.0 journey.We support our customers in digitalizing their products and services, leveraging our expertise in new technologies and digital transformation.As a Business Development Manager in Digital Transformation,...

We are seeking an experienced Upstream Scientist to join our Clinical Team in Manufacturing Product Support department. As a key member of our team, you will be responsible for supporting the production process of clinical products, ensuring error-free and timely execution.The ideal candidate has experience working in a cGMP environment and is familiar with...

At AM Group, we are committed to delivering exceptional results through innovative and effective process optimization strategies. As a Manufacturing Excellence Lead, you will be responsible for driving process excellence and ensuring successful execution of projects related to production of multiple types of pharmaceutical products.Key...

Lundbeck A/S is a global pharmaceutical company dedicated to transforming lives through innovative treatments for brain disorders. As a leading developer of life-changing medicines, we strive to make a meaningful difference in the lives of people affected by these conditions.As a Regulatory Expert in Pharmaceutical Quality Assurance, you will play a crucial...

About the RoleThe ideal candidate will have a strong understanding of compliance, architecture frameworks, and manufacturing IT layers, particularly in relation to the Purdue Model.Key Responsibilities:Design and implement infrastructure architecture for GxP-regulated environments.Ensure compliance with industry standards such as Good Automated Manufacturing...

Hvis du er en juridisk expert med interesse for digital regulering, så søger vi dig! Vi søger en engageret jurist til Kontor for digital regulering og tilsyn i Digitaliseringsstyrelsen. Du vil være en del af DSA-teamet, der er ansvarlig for at føre tilsyn med forordningen om digitale tjenester.Vores arbejde er afgørende for at fremme tillid og...

NKT A/S is a global leader in the production of high-voltage power cables, and we are seeking a highly skilled High Voltage Cable Quality Control Expert to join our team. In this role, you will be responsible for ensuring the highest quality standards are met in the development and manufacturing of our high-voltage cable solutions.Your expertise in quality...

As a QC Method Validation Expert, you will play a critical role in ensuring the accuracy and reliability of our analytical methods. You will work closely with our cross-functional teams to develop and implement methods that meet regulatory requirements, participate in operational planning, and ensure all activities follow cGMP guidelines.The QC Department is...

Key ResponsibilitiesThis position involves providing scientific and technical support for downstream purification processes, including process transfer and batch execution at CMOs. The ideal candidate will have extensive experience in downstream purification of peptide-/protein-based therapeutics and a strong understanding of GMP requirements.About the...

Select your preferred format: Microsoft Word or PowerPointAPI Manufacturing Capacity OptimizerIndustry: PharmaceuticalLocation:Capital Region of DenmarkWe are looking for an API manufacturing capacity optimizer to join our team in CMC API Pilots. As an optimizer, you will contribute to the development of new processes and optimize existing ones to enhance...

AGC Biologics is a leading Contract Development and Manufacturing Organization (CDMO) within the biotech industry, specializing in developing biopharmaceutical production processes and GMP production of biopharmaceutical proteins for clinical studies and commercial markets.We are seeking a skilled Manufacturing Technician to join our production team, which...

About the RoleThis is a unique opportunity to join Amazon's team as a Solutions Architect, working closely with some of the world's largest manufacturing companies to design and implement cloud-based solutions that drive business outcomes. The successful candidate will have a strong background in cloud computing, software development, systems engineering,...