- US Bank (Charlotte, NC)
- …management and quantitative backgrounds. + Interface with key stakeholders throughout validation process , regulators and internal audit to discuss justification ... at-all from Day One. **Job Description** US Bank is seeking an experienced Model Validation Director for our Treasury & Markets risk areas and will reside within the… more
- Lilly (Concord, NC)
- …best practices related to computerized systems, automation, and manufacturing process controls. Project Management: Manage validation deliverables across ... a subject matter expert. Continuous Improvement: Proactively identify opportunities for process improvement within TSMS validation , driving efficiency and… more
- ThermoFisher Scientific (Wilmington, NC)
- … validation strategies are science- and risk-based, in accordance with FDA Process Validation Guidance, Annex 15, and ICH principles, supporting PSG's ... & Cleaning Validation Leadership + Develop and review process validation protocols and reports, ensuring compliance and sound scientific rationale for APIs,… more
- ThermoFisher Scientific (Greenville, NC)
- …protocols and reports. + Validation related deviations and discrepancies. + Process Validation (PV), Cleaning Validation , and Computer System related ... Description** The Staff QA Engineer will lead the quality oversight of validation activities with a strategic focus on continuous improvement and regulatory… more
- Astellas Pharma (Sanford, NC)
- …(P&IDs), and User Requirement Specification (URS) development + Experience with process validation and lifecycle management + Experience supporting commissioning ... ** Process Engineer** Do you want to be part...Automation, Supply Chain, Warehouse, Technical Development, Quality, Regulatory, Facilities, Validation , and various vendors. This role is based in… more
- Lilly (Durham, NC)
- …interpretation, and release of data including data released from CM, stability, process validation , and reference standard characterization. + Utilizes technical ... perform testing as required. + Contribute to APR, tech transfer, and process validation as required. + Communicate effectively in both written and oral formats… more
- Fujifilm (Holly Springs, NC)
- …data to solve manufacturing problems * Leads execution of all aspects of process validation including ancillary process validation (small-scale ... protocols and reports summarizing investigations, studies and projects * Develops process validation strategy and oversees execution of manufacturing … more
- United Therapeutics (Research Triangle Park, NC)
- …Product (SAP), MasterControl, MiniTab, Trackwise, and Empower software systems + Continuous Process Validation experience + Knowledge of software validation ... and process development and improvement, implementation of product/ process verification, validation activities, and commercialization. Responsibilities for… more
- Astrix Technology (Holly Springs, NC)
- …and cleaning validation in compliance with GMP guidelines. + Assist in process validation and technical support for manufacturing activities. + Collect and ... work experience **Required Skills:** + Hands-on experience in GMP technical support, validation , engineering, or process development. + Knowledge of drug… more
- Amgen (Holly Springs, NC)
- …**Responsibilities include but are not limited to:** + Support technology transfer, process validation , and plant start-up + Provide technical leadership in ... + In-depth expertise in biologics process purification processes + Experience in process scale-up, technology transfer, process validation , process … more