- 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)
- **Position Overview** The Sr Engineer or Scientist of Process Validation 1 ensures that manufacturing processes meet the validation and regulatory ... 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
- Ingersoll Rand (Durham, NC)
- …operational excellence and compliance with cGMP standards. The Validation Engineer will identify opportunities for process improvements and support ... by applicable laws, regulations and ordinances. **Job Overview:** The Validation Engineer actively supports pharmaceutical containment manufacturing and… 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
- 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)
- **Position Overview** The Engineer / Scientist 3 of Process Analytics provides support and leads technology transfer and technical oversight activities during ... PAT application + Prior biologics drug substance and manufacturing experience, including process development, validation , and transfer + Experience leading new… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** The Senior IT Engineer 2, CSV is the Subject Matter Expert (SME) and leads tasks associated with Computer System Validation (CSV). This ... on all GxP Manufacturing and IT Computerized Systems as well as prepares validation documentation, maintains a validated state, with a focus on consistent policy… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** 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)
- **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** 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
- BioFire Diagnostics, LLC. (Durham, NC)
- …week onsite requirement. Relocation Assistance is not available for this position. The Process Engineer Intern will provide support on ongoing studies and ... through lab scale or scale-up process /product development studies, product and process validation . + Assist in the analysis of process and product… 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
