- ITW (Washington, NC)
- …conducted to provide for systems review. + Manage Internal Audit Program. New/Change Product/ Process Validation + Oversee management of validation activities ... appropriate protocols are written, identified actions are completed, and overall Validation reports are written. + Management of Implementation and Documentation of… more
- ManpowerGroup (Wilson, NC)
- …Proficiency in AutoCAD, SAP, and MS Project. + Demonstrated success in process improvement, equipment validation , and compliance. + Strong cross-functional ... **Job Title: Lead Process Engineer** **Location: Wilson, NC** **Pay Range: $90k-$130k**...troubleshooting, and corrective action implementation. + Oversee scale-up and validation of new products, ensuring regulatory and documentation compliance.… more
- Lilly (Concord, NC)
- …facility or area start up experience. + Previous equipment qualification and process validation experience. + Previous experience with Manufacturing Execution ... training, and leadership of the engineering group supporting asset delivery, process development, commissioning, qualification, validation , and startup of the… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …for technology transfer activities to new or existing CDMOs. + Oversee the process validation lifecycle (PPQ, CPV, etc.) ensuring compliance with global ... robust and compliant manufacturing processes through effective technology transfer, validation , process monitoring, and lifecycle management. This individual… 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
- Actalent (Winston Salem, NC)
- …GMP compliance and regulatory readiness. + Experience with technology transfer and process validation . + Proficiency in aseptic processing and cleanroom ... 6+ years (Master's) in MSAT or biopharma manufacturing. + Experience with process lifecycle management and validation . + Experience with regulatory submissions… more
- Fujifilm (Holly Springs, NC)
- …Management * Prior drug substance or manufacturing experience, including process validation , transfer, commercialization, and manufacturing support and ... analysis, peptide mapping, and physical appearance. * Ensures analytical testing of in- process , drug substance (DS), drug product (DP), and stability samples is… 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
- Lilly (Concord, NC)
- …C&Q / Verification and Validation oversight including automation and computer systems validation + Use process knowledge and control strategy to make quality ... better for people around the world. **Responsibilities:** The Quality Assurance Process team member is responsible for demonstrating leadership, teamwork, and… more