Search the 17 jobs at FUJIFILM Diosynth Biotechnologies

As a Resilience Engineer, you will lead cross-functional investigations into quality deviations, synthesize data to identify root causes, and ensure timely documentation and communication of findings. You'll facilitate learning and risk reduction efforts while presenting status updates during audits and inspections.

As a GXP Specialist at FUJIFILM Diosynth Biotechnologies, your role involves managing supplier and audit documentation, ensuring compliance with regulations, supporting change controls, and maintaining quality systems. You will engage with internal stakeholders and oversee quality agreements while coordinating TrackWise workflows and audit responses.

The Customer Program Quality Manager is responsible for ensuring quality assurance during Tech Transfers and communicating quality-related topics with customers. The role involves establishing Quality Agreements, supporting manufacturing activities, and maintaining quality documentation while driving continuous improvement efforts.

As a Customer Program Quality Scientist, you will communicate with customers regarding quality issues, manage deviations and change controls, prepare KPI data, and maintain department documents while supporting continuous improvement initiatives.

The Program Manager will lead programs related to the manufacturing of drug substances and products, acting as the primary liaison between customers and internal teams. Responsibilities include planning, executing programs, financial oversight, risk management, and ensuring compliance with quality regulations.

The Strategic Sourcing/Category Manager will lead sourcing categories in pharmaceutical manufacturing MRO, professionalizing sourcing efforts, executing projects, conducting market evaluations, managing supplier relationships, and collaborating with internal stakeholders to improve sourcing practices.

The Senior Automation Engineer will lead tech transfer processes for new products, manage vendor deliverables, ensure automation solutions meet process requirements, and support daily manufacturing. Responsibilities include the configuration of DeltaV systems and collaboration with stakeholders to implement robust automation solutions.

As a Senior QA Specialist, you will be responsible for releasing materials for manufacturing, managing customer changes, approving specifications, handling complaints, and supporting quality oversight of the supply chain. You will collaborate with various stakeholders and be involved in projects, ensuring compliance and quality standards are met.

The Senior QA for QC Specialist will oversee quality assurance activities for the QC laboratory, review and approve relevant documentation, assess deviations, ensure compliance with procedures, and support training and communication among stakeholders. This role emphasizes collaboration within the QA team and with QC colleagues to maintain high quality standards.

The Responsible Engineer for Downstream Process Engineering will focus on tech transfer activities, ensuring readiness of downstream equipment for manufacturing biopharmaceuticals. Responsibilities include scoping equipment modifications, driving change management, providing technical support, and conducting training for production teams within a collaborative engineering environment.

The Stability Scientist will manage stability studies, support quality procedures, and collaborate with various stakeholders within the organization and with customers. They will ensure high performance in drug substance production and product release in a dynamic Quality environment.

The Automation Engineer will implement new DeltaV systems to support expansion projects, troubleshoot DeltaV code, review specifications, and collaborate with engineering partners to develop automation solutions. Key responsibilities also include participating in quality activities and ensuring compliance with defined procedures for automation systems.

The GXP Compliance Specialist will support compliance in GMP-related matters within the Supply Chain. Key tasks include managing deviations, supplier complaints, change controls, and ensuring compliance with GMP documents. The role requires coordination with stakeholders and will involve training sessions, audit preparations, and supporting continuous improvement projects.

Seeking a Senior Project Manager for the Strategic Projects team in Hillerod. Responsible for leading and managing CapEx projects in the pharmaceutical and biotech industry, ensuring safe project execution and compliance with regulations. Overseeing project governance, design, construction, safety, and quality activities. Leading projects related to drug product and finished goods areas, as well as technology transfer projects. Joining a team of 8 colleagues and reporting to the Director of Strategic Projects.

The Chromatography Expert/Senior Scientist will be responsible for overseeing chromatographic assays, improving testing processes, ensuring compliance with cGMP standards, and supporting the expansion of QC capabilities. The role involves troubleshooting, method validation, and collaboration within a dynamic team to improve efficiencies in the QC department.

The Global Principal Desktop Engineer is a senior technical role focused on monitoring, managing, and troubleshooting end user computing across the organization. Responsibilities include providing Level 3 support, diagnosing complex technical issues, mentoring junior engineers, and managing client build and software deployment processes.

The Analytical Project Manager will oversee method transfer activities related to Drug Substance and Drug Product testing. Responsibilities include leading meetings, generating transfer plans, and contributing to optimization projects. The role demands effective communication and stakeholder management in a dynamic QC laboratory environment.