- Amgen (Holly Springs, NC)
- …role you will advance Amgen latest bioprocessing platform and technology, delivering high quality of medicine to patients around the world. The Sr. Engineer will be ... but are not limited to:** + Support technology transfer, process validation , and plant start-up + Provide technical leadership in **Downstream (Purification)**… more
- Genentech (Holly Springs, NC)
- …partner and collaborate with our partner organizations (Engineering and MSAT, Quality , Supply Chain, Technical Development, Regulatory, CMO, Strategy) to provide ... expertise in project management and technical design, testing, qualification, validation , as well as all other activities related to design and start-up a new Drug… more
- Catalent Pharma Solutions (Greenville, NC)
- …Catalent's Greenville, NC facility by leading analytical teams in method development, validation , and testing for oral solid dosage forms. It ensures high- quality ... + Lead in the development of a climate of quality and safety within the teams, by identifying and...as required, CMOs. + Author and review analytical procedures, validation documents, portions of regulatory submissions for site pre-commercial… more
- Actalent (Whitsett, NC)
- …and provides technical training to enhance operational readiness and product quality . Responsibilities + Build and configure test network environments including ... + Set up and maintain test servers (L1/L2) used in automated and manual validation processes. + Document and escalate issues with detailed root cause analysis and… more
- Merck (Durham, NC)
- …The site includes clean utilities, facilities equipment, manufacturing production equipment, quality labs and a warehouse. The candidate will support the ... Maintenance (PM) plans as requested. Responsible for SAP transactions, validation testing support, supporting root cause investigations and change control… more
- Fujifilm (Holly Springs, NC)
- …Experience with laboratory equipment, utilities qualification, environmental monitoring qualification, quality systems, automation, IT systems, and/or validation ... working knowledge of LIMS, Smartsheet, Track wise, Master Control, and/or Kneat validation software + Experience with management of complex projects + Experience and… more
- Novant Health (Winston Salem, NC)
- …Medical Assistant to coordinate and assist healthcare providers in delivering safe, quality , and cost-effective care to our diverse patient population. This role ... histories + Prepare patients and exam rooms for treatment + Ensure safe, quality , and cost-effective care for patients. + Foster a safe patient environment driven… more
- Sumitomo Pharma (Raleigh, NC)
- …for critical GxP systems supporting Clinical Supply Chain, Commercial Operations, Quality Management, and Manufacturing. + Lead the integration strategy and ... Chain of Identity (CoI)-crucial in CGT-into compliant and scalable system solutions. GxP, Quality & Compliance + Own and enforce GxP compliance for all in-scope… more
- Oracle (Raleigh, NC)
- …strategies, and user experience. + Drive the creation and curation of high- quality datasets required for training and validating agent models, including annotation ... guidelines and domain coverage. + Develop validation protocols to test agent performance, usability, and clinical...and quickly iterate product development. + Establish adoption and quality signals for the experience and use these to… more
- Fujifilm (Holly Springs, NC)
- …Transfer (TT) of drug substance (DS) and drug product (DP) into the Quality Control laboratories of FUJIFILM Biotechnologies Diosynth Holly Springs (FDBN). This role ... supports the transfer and validation of methods such as residuals (HCP, DNA, Protein...cross-functionally with Contract Laboratory Organizations (CLOs), QC testing teams, Quality Assurance (QA), and Process Science groups to ensure… more