Technology Transfer Jobs in Holly Springs (NC)
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Search Results - Technology Transfer Jobs in Holly Springs (NC)
Holly Springs (NC)icims.com
Position Overview:
The Senior Engineer, QA Operations Technology Transfer is responsible for establishing and maintaining a robust and efficient Technology Transfer program at the Holly Springs, NC site. This position is responsible for ensuring...
Amgen IncHolly Springs (NC)
and UFDF skids as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc.
• Experience with Tech Transfer, Process Design, and Commissioning & Qualification...
Holly Springs (NC)icims.com
validation requirements (e.g., worst-case soiling for cleaning validation, microbial hold, and mixing validation)
• Supports process sub-teams throughout the phases of technology transfer (TT)
• Leads generation of sampling plans for process validation...
Amgen IncHolly Springs (NC)
Filtration skids, UFDF), and CIP/SIP Skids.
• Experience with Tech Transfer, Process Design, and Commissioning & Qualification.
• Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.), experience interacting with regulatory agencies...
Holly Springs (NC)icims.com
technology transfer, and manufacturing operations while ensuring processes are efficient, scalable, compliant with Current Good Manufacturing Practice (CGMP) regulations. This role adheres to product and customer requirements and works toward optimizing plant...
Disability SolutionsHolly Springs (NC)
and/or operational) in Visual Inspection drug product manufacturing.
• You have relevant experience in data science/engineering, analytics, IT etc. to drive the concept of smart factory is desirable
• You have prior experience with technology transfers, process...
Holly Springs (NC)icims.com
/7 environment—driving documentation excellence, tech transfer readiness, and continuous improvement across Drug Product Finished Goods.
Company Overview:
FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North...
Holly Springs (NC)icims.com
generating milestones throughout the scope of the program (contract sign, AD, Tech transfer, Clinical¬ Commercial Mfg, QA, QC, Release, Ship deliverables, Transfer in (materials/eqpt, methods, documentation), Transfer out (materials/eqpt, methods...
Holly Springs (NC)icims.com
manufacturing schedules
• Continuous improvement initiatives, escalation, and mitigation of manufacturing issues
• Cross-site or local manufacturing projects
• Technology transfer manufacturing deliverables
• Assistance during regulatory inspections and audits...
Holly Springs (NC)icims.com
process verification, and continuous improvement. This role drives technology transfer (TT) of new and existing drug product processes into and between sites, ensuring robust process fit, compliant documentation, and readiness through close collaboration...
Holly Springs (NC)icims.com
manufacturing operations.
• Support technology transfer activities within manufacturing.
• Ensure safety and cGMP compliance in all manufacturing environments.
• Manage/perform/support quality records including change management, investigations, CAPAs...
Holly Springs (NC)icims.com
and the success of technology transfers and inspections.
What you’ll do
During project phase:
• Support operational readiness initiatives as well as site commissioning and qualification efforts.
In operations:
• Support troubleshooting, acting as a process...
Holly Springs (NC)icims.com
Support technology transfer, ensuring seamless introduction and scale-up of processes within manufacturing.
• Initiate or support change management records, investigations, corrective and preventive actions, and continuous improvement activities...
Holly Springs (NC)icims.com
area within QC Raw Materials. You will be working closely with the small team handling materials to enable the readiness of the drug product facility. Additionally, you will be involved in tech transfers for new customers and their products at FUJIFILM...
Holly Springs (NC)icims.com
operations.
• Support technology transfer activities within the manufacturing domain.
• Ensure compliance with safety procedures and cGMP requirements in the manufacturing environment.
• Manage, perform, initiate, or support change management records...
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