- Fujifilm (Holly Springs, NC)
- **Position Overview** The Engineer or Scientist 2 for Process Validation helps ensure that manufacturing processes meet the validation and regulatory ... This role contributes to the design, execution, and documentation of process validation protocols for equipment, systems, and manufacturing processes.… more
- ManpowerGroup (Morrisville, NC)
- Our client, a leader in the technology industry, is seeking a Silicon Validation Engineer to join their team. As a Silicon Validation Engineer , you will ... will align successfully in the organization. **Job Title:** **Silicon Validation Engineer ** **Location: Raleigh, NC** **What's the...in it for me?** + Opportunity to perform post-silicon validation on cutting-edge IPs in a leading process… more
- Amazon (Raleigh, NC)
- …AWS sites and Asia. Key job responsibilities * Develop and implement detailed validation plans tailored to specific hardware designs * Collaborate with design and ... and test against product requirements * Analyze and interpret data from validation tests, offering insights and recommendations * Design and document validation… more
- Fluor (Raleigh, NC)
- …Greenville South Carolina. The PDS is a global team of subject matter experts, process architects, process , and equipment engineers within the ATLS Division of ... through credibility. Become their trusted partner. * Lead the development of validation master plan development projects. * Leverage existing client relationships to… more
- Teleflex (Morrisville, NC)
- Senior R&D Process Engineer , Injection Molding **Date:** Mar 11, 2025 **Location:** Morrisville, NC, US **Company:** Teleflex **Expected Travel** : Up to 25% ... that make a difference in patients' lives. **Position Summary** The Senior R&D Process Engineer (Plastics) is responsible for leading and coordinating the … more
- Amgen (Holly Springs, NC)
- …Join us and transform the lives of patients while transforming your career. **Senior Process Engineer - Clean Utilities** **What you will do** Let's do this. ... upon start up. + Provide system ownership for Biopharmaceutical process equipment. Identify, support, and/or lead implementation of engineering-based improvements… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** The Senior Engineer or Scientist 2 of Process Analytics serves as the subject matter expert (SME) and provides technology transfer support, ... Requirements** + Prior biologics drug substance and manufacturing experience, including process development, validation , and transfer + Experience authoring CMC… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** This position reports to the Process Engineering Manager, Downstream in support of the Process Equipment team for the Aura project, a ... in Holly Springs, NC. The initial assignment is to assume the Responsible Engineer role for **Chromatography** and **Column Packing** unit operations. As the site… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** This position reports to the Process Engineering Manager, Upstream in support of the Process Equipment team for the Galaxy project, a ... NC. The initial assignment is to assume the Responsible Engineer role for the **Seed Train** unit operations. As...2025, this position is planned to continue as a Process Engineering role supporting commercial operations, technology transfers, and… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** The QA Engineer for Quality Control (QC) Compliance will be responsible during the project phase, to help drive the Quality oversight for all ... processes, through operational readiness, as well as provide oversight of validation program execution for these processes. This role will also collaborate… more
- Fujifilm (Holly Springs, NC)
- …new manufacturing documents in support of TT e. Supports and approves of process validation protocols and documentation (PPQ, process -specific cleaning ... **Position Overview** The Sr. Engineer , Quality Assurance is responsible for establishing and...position interacts cross-functionally with Manufacturing, Supply Chain, Quality Control, Process Sciences, Validation , and various Client functions… more
- Mallinckrodt Pharmaceuticals (Raleigh, NC)
- …Skills/Qualifications: Other Skills: Competencies: Understanding of GMPs (ICH Q7) and process validation Understanding of Six Sigma and Lean Manufacturing ... day-to-day production, optimize plant operation, resolve operational issues, and investigate process deviations. The Sr. Production Engineer will provide… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** The QA Engineer , Quality Control (QC) Materials Support oversees Quality Assurance during the operational phase. This role and the ... for the QC laboratory program * Assesses the impact of system and process modifications and maintains oversight of change management processes to ensure laboratory… more
- Pfizer (Sanford, NC)
- …Achieve** In this role, you will: + The primary role of the automation engineer is to support the assigned Manufacturing Area by responding to the day-to-day ... + Support responsibilities may consist of: master data maintenance, validation support, change coordinator, user change management, performance monitoring, periodic… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** The Quality Assurance Operations Engineer DSM (Night) is responsible to help drive the Quality oversight for the direction of all Drug ... release and WO oversight * Provides oversight and approval of system and process lifecycle documentation, including risk and impact assessments, product, process … more
- Fujifilm (Holly Springs, NC)
- …Helps to assess the impact of Computer System modifications through the change control process + Helps to maintain the validation status of DSM Automation ... **Position Overview** The Automation Engineer 2, CSV will provide support to the...the Drug Substance Manufacturing (DSM) facility. This includes preparing validation documentation, contributing to the qualification of Drug Substance… more
- Mentor Technical Group (Holly Springs, NC)
- …Functions: + Provide engineering, troubleshooting support and technical expertise for process equipment and site utilities as needed. + Proactively identify ... infrastructure, connectivity and capacity assessments. + Lead and manage process improvements, corrective and preventive actions (CAPAs) and change controls… more
- J&J Family of Companies (Raleigh, NC)
- …**Job Description:** Johnson & Johnson is currently seeking a **Senior Automation Engineer , Delta V** to join our MAKE Asset Management Organization located in ... Automation professionals with various technical expertise, responsible for the implementation, validation , qualification and maintenance of the ISA-95 level 1 and 2… more
- Insight Global (Holly Springs, NC)
- …These engineers will support drug substance manufacturing buildings and help support process equipment. Process Equipment includes, but not limited to ... Skids, Transfer Stations, Harvest/Centrifugation, Seed and Production Bioreactors. The engineer will collaborate with cross-functional teams to support the… more
- Fujifilm (Holly Springs, NC)
- …transfer (TT) across multiple unit operation + Coordinates, plans, and executes manufacturing process validation runs + Supports design and leads generation of ... **Position Overview** The Engineer / Scientist 3, Downstream MSAT will provide...sampling plans for process validation reports (PVRs) and investigations +… more