• Process Validation Engineer

    Teleflex (Morrisville, NC)
    Process Validation Engineer **Date:** Nov 28, 2024 **Location:** Morrisville, NC, US **Company:** Teleflex **Expected Travel** : Up to 25% **Requisition ID** ... a difference in patients' lives. **Position Summary** Under general direction, the Process Validation Engineer in our Morrisville, NC facility is responsible… more
    Teleflex (11/09/24)
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  • Sr Engineer - Scientist 1, Process

    Fujifilm (Holly Springs, NC)
    …Holly Springs, North Carolina, United States. **External US** **About This Role** The Sr Engineer or Scientist of Process Validation 1 ensures that ... normal operating conditions. This role involves designing, executing, and documenting process validation protocols for equipment, systems, and manufacturing… more
    Fujifilm (10/24/24)
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  • Senior Engineer Analytical - QC System…

    Amgen (Holly Springs, NC)
    …+ High school diploma / GED and 10 years of cGMP laboratory, analytical instrument validation , and/or Process Engineer experience OR + Associate's degree and ... 8 years of cGMP laboratory, analytical instrument validation , and/or Process Engineer OR + Bachelor's degree and 4 years of cGMP laboratory, analytical… more
    Amgen (12/13/24)
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  • Engineer Analytical - QC System Owner

    Amgen (Holly Springs, NC)
    …+ High school diploma / GED and 8 years of cGMP laboratory, analytical instrument validation , and/or Process Engineer experience OR + Associate's degree and ... 6 years of cGMP laboratory, analytical instrument validation , and/or Process Engineer OR + Bachelor's degree and 2years of cGMP laboratory, analytical… more
    Amgen (12/13/24)
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  • Manager, Clinical Data Validation

    Takeda Pharmaceuticals (Raleigh, NC)
    …to take charge of your future at Takeda. Join us a Manager, Clinical Data Validation Engineer in our Cambridge, MA office. At Takeda, we are transforming the ... the "Apply" button, I understand that my employment application process with Takeda will commence and that the information...trial deliverables. As part of CDE, the Clinical Data Validation Engineer (DVE) group leads validation more
    Takeda Pharmaceuticals (12/06/24)
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  • CQV / Validation Engineer

    Verista (Durham, NC)
    …manufacturing equipment. + General understanding of capital equipment implementation and process knowledge. + Understanding validation documents, URS, IQ, OQ, ... + Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/ software, and processes as… more
    Verista (12/10/24)
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  • Sr. Automation Engineer I/II, Principal…

    Grifols Shared Services North America, Inc (Clayton, NC)
    …instrumentation, process , utilities, or qualification testing. The Senior Automation Engineer I meets customer needs in support of business goals. In addition, ... instrumentation, process , utilities, or qualification testing. The Principal Automation Engineer meets customer needs in support of business goals and is… more
    Grifols Shared Services North America, Inc (12/09/24)
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  • Automation Engineer I, II, Sr. Automation…

    Grifols Shared Services North America, Inc (Clayton, NC)
    …provides automation support for projects or within a specific area, or provide validation support for automation projects. The Automation Engineer I can also ... provides automation support for projects or within a specific area or provide validation support for automation projects. The Automation Engineer II will also… more
    Grifols Shared Services North America, Inc (10/09/24)
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  • Sr. Chemical Process Engineer

    Mallinckrodt Pharmaceuticals (Raleigh, NC)
    Job Title Sr. Chemical Process Engineer Requisition JR000014522 Sr. Chemical Process Engineer (Open) Location Raleigh, NC Additional Locations Job ... Skills/Qualifications: Other Skills: Competencies: Understanding of GMPs (ICH Q7) and process validation Understanding of Six Sigma and Lean Manufacturing… more
    Mallinckrodt Pharmaceuticals (10/08/24)
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  • Process Engineer

    BioFire Diagnostics, LLC. (Durham, NC)
    …create draft validation master templates. + Provide support to Quality Validation Department for equipment and process periodic reviews. + Provide support ... or exceed production targets and quality. Provide Commissioning, Qualification and Validation (CQV) and project management oversight to ensure assets are efficiently… more
    BioFire Diagnostics, LLC. (12/09/24)
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  • Downstream Process Engineer

    Amgen (Holly Springs, NC)
    …waste, as part of Amgen's plan to be a carbon-neutral company by 2027. **Downstream Process ** ** Engineer ** **What you will do** Let's do this. Let's change the ... vital role the Engineer reports to the Senior Manager of the Process Engineering group. The position is responsible for providing daily Engineering support at… more
    Amgen (12/12/24)
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  • Senior Process Engineer - Clean…

    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
    Amgen (11/15/24)
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  • Associate Process Engineer

    BioFire Diagnostics, LLC. (Durham, NC)
    …Summary & Responsibilities: As part of the Industrialization department, the Associate Process Engineer will develop and/or manage process improvement ... of in vitro diagnostics. Within this role the Associate Process Engineer will be required to interface... protocols as required by the change control and validation programs. + Analyze process and product… more
    BioFire Diagnostics, LLC. (12/17/24)
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  • QA Engineer , Digital Technologies

    Fujifilm (Holly Springs, NC)
    …North Carolina, United States. **External US** **About This Role** The QA Engineer , Digital technologies is responsible to partner in the Quality oversight of ... through to operational readiness, as well as provide oversight of validation program execution for these systems. Collaborates within the Digital Technologies… more
    Fujifilm (11/01/24)
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  • Sr. IT Engineer 2, CSV

    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...IT Quality Management Systems (QMS) + Identifies and drives process improvement and implementation ideas to improve efficiencies +… more
    Fujifilm (10/05/24)
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  • Process Engineer III - Manufacturing…

    Novo Nordisk (Durham, NC)
    …equipment and serving as the gatekeeper for all related standards. As the Sr Process Engineer supporting MSAT, this role will primarily s upport complex ... the completion of development studies, technology transfer, commercial scale-up, and support process validation and optimizations as needed for PAT equipment.… more
    Novo Nordisk (12/11/24)
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  • Process Engineer 2, Chromatography…

    Fujifilm (Holly Springs, NC)
    …United States. **External US** **About the Role:** This position reports to the Process Engineering Manager, Downstream in support of the Process Equipment team ... 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 (11/21/24)
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  • Process Engineer 3 - Seed Train…

    Fujifilm (Holly Springs, NC)
    …United States. **External US** **About the Role** This position reports to the Process Engineering Manager, Upstream in support of the Process Equipment team ... 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 (11/21/24)
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  • Quality Engineer II - Solid Dose

    United Therapeutics (Research Triangle Park, NC)
    …and approve GMP related documents (ie IOQ and PQ documents, process validation protocols, analytical/microbiological method validations, stability protocols, ... combination product/medical devices. This role will support the implementation of process qualification and validation activities and commercialization including… more
    United Therapeutics (12/11/24)
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  • Sr. New Product Development Quality…

    Eaton Corporation (Raleigh, NC)
    …Lessons Learned feedback, input, data and deliverables to the new product development process including the project plan, validation , pFMEAs (Design and ... Eaton's Electrical division is currently seeking a New Product Development Quality Engineer . This position will be a hybrid office (3x2) role located in Raleigh, NC.… more
    Eaton Corporation (12/07/24)
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