- Novo Nordisk Inc. (Durham, NC)
- …our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate ... SOP development; maintenance development & training & management of cost, quality & schedule within area of responsibility. Establish & maintain positive… more
- United Therapeutics (Durham, NC)
- …diseases, and other orphan diseases. **How you'll contribute** The Lead Validation Engineer , performs both functional/technical expertise and leadership ... expert on project teams to provide guidance and leadership. The Lead Validation Engineer oversees and performs simultaneous activities for multiple projects.… more
- Amgen (Holly Springs, NC)
- …waste, as part of Amgen's plan to be a carbon-neutral company by 2027. ** Engineer , Process Development (Process Validation & Business Strategy)** **What you will ... Manufacturing Facility. This position is part of the Process Validation & Business Strategy (PBS) team within PD DST....the position. As an organization dedicated to improving the quality of life for people around the world, Amgen… more
- Amazon (Raleigh, NC)
- …be passionate about the role testing plays in achieving product reliability and quality . Applying skills in developing new test processes, test automation and debug ... AWS sites and Asia. Key job responsibilities * Develop and implement detailed validation plans tailored to specific hardware designs * Collaborate with design and… more
- Lenovo (Morrisville, NC)
- RAS Validation Engineer **General Information** Req # WD00071459 Career area: Hardware Engineering Country/Region: United States of America State: North Carolina ... is looking for a RAS (Reliability, Availability and Serviceability) Engineer for our product assurance team to develop test...teams and research vendor tools, to help meet our quality and validation goals. **Position Requirements:** +… more
- Verista (Durham, NC)
- …expertise Responsibilities: + Managing and working collaboratively with clients' quality representative to complete deviation investigation and resolution for ... + Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/ software, and processes as… more
- ManpowerGroup (Raleigh, NC)
- …6-12 Month contract with right to hire 1 opening The Commissioning, Qualification, and Validation Engineer , Engineer II and Senior Engineer report ... travel may be required. **Expectations:** - The CQV Engineer and Engineer II performs commissioning, qualification, and validation testing on manufacturing… more
- Fujifilm (Holly Springs, NC)
- …Springs, North Carolina, United States. **External US** **About This Role** The Quality Assurance Sr. Engineer , DSM Disposition, is responsible for establishing ... improvement. This position interacts cross-functionally with Manufacturing, Supply Chain, Quality Control, Process Sciences, Validation , and various Client… more
- Fujifilm (Holly Springs, NC)
- …in GMP Quality Assurance and/or similar role * Experience in Validation , cGMP manufacturing operations and/or Quality oversight, in an FDA regulated ... US** **About This Role** **During Project phase:** * Partners in the Quality oversight of Drug Product processes such as formulation, fill, inspection through… more
- BD (Becton, Dickinson and Company) (Durham, NC)
- …grow and become your best self. Become a **maker of possible** with us. The Staff Quality Engineer is a key member of the New Products Development Team and is ... quality aspects of the design control process: quality planning; verification and validation planning and...the development and/or maintenance of products or services. The Engineer is involved in resolving the equipment and process-related… more
- Fujifilm (Holly Springs, NC)
- …North Carolina, United States. **External US** **About This Role** The Senior IT Engineer 2, CSV is the Subject Matter Expert (SME) and leads tasks associated ... with Computer System Validation (CSV). This role provides input and determine action...the allocation of contract CSV resources and monitors the quality of their deliverables to support local IT projects… more
- Fujifilm (Holly Springs, NC)
- …North Carolina, United States. **External US** **About the Role:** The CQV Engineer 2 supports the commissioning and qualification of equipment and systems for ... the site. This role coordinates with the CQV team to perform validation activities to include but not limited to equipment set up, building dashboards, and reading… more
- Fujifilm (Holly Springs, NC)
- …**External US** **About This Role** The Sr. Engineer , Supplier Quality , provides supplier oversight ... or materials to Fujifilm Diosynth Biotechnologies are of the highest quality while conforming to pre-established requirements including cGMPs. This role primarily… more
- Fujifilm (Holly Springs, NC)
- …in GMP Quality Assurance and/or similar role + Experience in Validation , cGMP manufacturing operations and/or Quality oversight, in an FDA regulated ... Holly Springs, North Carolina, United States. **External US** **About This Role** The Quality Program Manager is accountable for programs from the point of initial… more
- BioFire Diagnostics, LLC. (Durham, NC)
- Position Summary: Sr. Mechanical Engineer for highly automated packaging lines. The purpose of this role is to actively support packaging line engineering and ... for the bioMerieux, Inc. Durham Manufacturing Facility to produce cost effective quality product which meets all applicable regulatory standards and the needs of… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …and create draft validation master templates. + Provide support to Quality Validation Department for equipment and process periodic reviews. + Provide ... product line are available to meet or exceed production targets and quality . Provide Commissioning, Qualification and Validation (CQV) and project management… more
- BD (Becton, Dickinson and Company) (Durham, NC)
- …(with Marketing, Medical Affairs, Regulatory, Service, Operations, Project Management, and Quality ) + The Senior Staff Systems Engineer models and ... pharmacy management software solutions. BD is searching for a Senior Staff Systems Engineer to join this rapidly expanding team to lead robust systems engineering… more
- Lilly (Durham, NC)
- …better for people around the world. Organization Overview: The Sr. Principal Process Engineer for Parenteral role is a technical position that supports the asset ... delivery, process development, commissioning, qualification, validation , and startup of the associated processes and equipment in the Parenteral manufacturing area.… more
- Microsoft Corporation (Raleigh, NC)
- …deploy new offerings and hardware infrastructure on time, in high volume with high quality and lowest cost is of paramount importance. To achieve this goal, the ... measures of success for hardware manufacturing, improving the planning process, quality , delivery, scale and sustainability related to Microsoft cloud hardware. We… more
- Fujifilm (Research Triangle Park, NC)
- **Overview** **Lab Engineer II** is a mid-level position in the Laboratory Engineering department of FDBU. The primary purpose of this position is to provide day to ... day technical support for the analytical equipment within Manufacturing, Quality Control, Analytical and Process Development organizations. In addition, this… more
