- US Tech Solutions (Holly Springs, NC)
- …for site. These activities will involve facilities/utilities, equipment/systems, computerized systems, process and validation maintenance, with an emphasis on ... support and oversight of the commissioning & qualification and process qualification at with the focus on Computer System... qualification at with the focus on Computer System Validation and Automation support. This individual will work alongside… more
- Merck (Wilson, NC)
- …with high liability to projects of varying scopes. Expertise in qualification and process validation practices for complex systems is essential to success in ... includes support for equipment design, equipment qualification, process demonstration, process performance qualification, and process validation . +… more
- GE Aerospace (Asheville, NC)
- …and work instructions. + Troubleshoot & prove-out processes and programs, direct process validation activities, and validate work using multiple techniques. + ... **Job Description Summary** The CMC Manufacturing Engineer will be a process owner for air flow inspection in the Asheville plant. The process owner will be… more
- Ryder System (Raleigh, NC)
- …project lead on identifying gaps in vendor FSD/SOW using the FSD Checklist process + Design Validation :* Provide input on automation solution designs to ... lead engineer on major RFP projects by leading automation selection and validation on new business sale projects by identifying potential automation technologies.*… more
- Fujifilm (Holly Springs, NC)
- …Management. + Prior drug substance or manufacturing experience, including process validation , transfer, commercialization, and manufacturing support and ... criteria. + Relevant experience in analytical method development and validation . + Demonstrated application and knowledge of ICH guidelines...who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any… more
- Fujifilm (Holly Springs, NC)
- …PPQ strategies globally, as required * Coordinates, plans, and supports manufacturing process validation runs * Facilitates technical risk assessments for new ... (GMP) environment * Prior drug substance or manufacturing experience, including process validation , transfer, commercialization, and manufacturing support and… more
- ThermoFisher Scientific (Greenville, NC)
- …immediate and controlled-release dosage forms. + In-depth knowledge of GMP, process validation , and regulatory requirements. + Strong problem-solving, ... data science or statistical analysis tools (eg, Python, MATLAB) to support process development and optimization is highly desirable. Your expertise will be essential… more
- Fujifilm (Holly Springs, NC)
- …Management. + Prior drug substance or manufacturing experience, including process validation , transfer, commercialization, and manufacturing support and ... manufacturing facility, from first campaign through commercialization (clinical through process performance qualification/commercial). This role interfaces with customers and… more
- Lilly (Concord, NC)
- …+ Facility, Equipment, Systems Start-up + Equipment design, qualification, and process validation . + Manufacturing Execution Systems and electronic batch ... the project phase, the Operations Manager (OM) will support commissioning, qualification, and validation of the Device Assembly and Packaging (DAP) areas as well as… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …of QC staff + Perform the Tracking System Deployment for Stability Samples/ Process Validation Samples etc. + Perform the Training Tracking Tool/Software for ... procedures and systems for RM, PM, FD and in process testing in QC lab. Provide information, data for...transfer of analytical methods for new products. Execute cleaning validation of new products. + Assist in the monitoring… more
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