- Novo Nordisk Inc. (Durham, NC)
- …Novo Nordisk and help us make what matters. The Position The QC Automation Engineer role will provide support & management of hardware & software on quality control ... assessments & testing of operating systems, software, & hardware Perform automation/IT validation activities in accordance with Novo Nordisk procedures & FDA 21 CFR… more
- Merck & Co. (Durham, NC)
- …are seeking a Growth and Improvement minded Associate Specialist Automation Engineer who can help drive our Strategic Operating Priorities.- The Automation ... Engineer is a member of the Automation team responsible for the support of process control systems used in manufacturing operations located in Durham, NC.- We… more
- Teleflex (Morrisville, NC)
- Process Validation Engineer **Date:** Jan 25, 2025 **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
- Fujifilm (Holly Springs, NC)
- …Holly Springs, North Carolina, United States. **Job Description** **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
- 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 (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
- 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
- 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
- BioFire Diagnostics, LLC. (Durham, NC)
- Position Summary & Responsibilities: The Validation Engineer is responsible for developing, supporting and implementing basic validation initiatives to ... support the site goals and objectives. The Validation Engineer will be responsible for...etc. In addition provide support to other aspects of validation related to process , test method, software,… more
- 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
- 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
- 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
- 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 (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)
- **Overview** **About This Role** The Engineer / Scientist 3 of Process Analytics provides support and leads technology transfer and technical oversight ... PAT application + Prior biologics drug substance and manufacturing experience, including process development, validation , and transfer + Experience leading new… more
- J&J Family of Companies (Raleigh, NC)
- … process activities, (including those related to verification or validation activities), determines criteria and subsequently generates summary (or final) ... Johnson & Johnson is recruiting for a Sr Quality Engineer for Shockwave Medical Inc. located in United States. At Johnson & Johnson, we believe health is everything.… more
- Fujifilm (Holly Springs, NC)
- …North Carolina, United States. **Job Description** **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 (Holly Springs, NC)
- …United States. **Job Description** **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 (Holly Springs, NC)
- …United States. **Job Description** **About the Role:** This position reports to the Process Engineering Manager, Downstream in support of the Process Equipment ... 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)
- …United States. **Job Description** **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
