• Process Validation Engineer

    Teleflex (Morrisville, NC)
    Process Validation Engineer **Date:** Dec 27, 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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  • Hardware Validation Engineer , NPD…

    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
    Amazon (11/16/24)
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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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  • Cleaning Validation Associate

    Pfizer (Sanford, NC)
    …Your documentation skills will guide the writing, review and approval of for validation process documents and technical reports related to equipment, products ... cGMP} and site training initiatives. + Report to the Validation Section Manager, the Validation Engineer...+ Technical writing experience + Pharmaceutical Industry with laboratory process validation experience + Working knowledge of… more
    Pfizer (01/04/25)
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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 (01/08/25)
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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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  • 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. (01/02/25)
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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 (01/07/25)
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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 Engineer ( Process

    Actalent (New Hill, NC)
    Job Title: Associate Engineer ( Process Engineer )Job Description We are seeking a dedicated Associate Process Engineer to join our team. This position ... degree in engineering or related technical field. + Associates degree and 4 years of Process Engineer experience or High school diploma/GED and 6 years of … more
    Actalent (01/07/25)
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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 (01/04/25)
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  • Process Engineer 3 - Upstream Media…

    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. ... The initial assignment is to assume the Responsible Engineer role for **Media Prep** unit operations. As the...* Reviews piping and instrumentation diagram (P&IDs) and other process design documents * Provides direction to detailed design… more
    Fujifilm (01/04/25)
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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 I - Fermentation

    Novo Nordisk (Clayton, NC)
    …installed design adheres to process requirements. Coordinate & execute process validation activities. Provide technical support of the operating facility ... & execution of the project phases for the Fermentation process , evolving into a process subject matter...Process Support - API. Essential Functions + Overall validation responsible within area + Execute & coordinate all… more
    Novo Nordisk (01/10/25)
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  • Process Engineer (Holy Springs,…

    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
    Mentor Technical Group (11/22/24)
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