- Fujifilm (Holly Springs, NC)
- …to ensure full CGMP compliance by operations launch * Ensures the integration of process validation (PV), CV, and computerized system validation (CSV) into ... **Position Overview** The Associate Director, Cleaning Validation is responsible...and in alignment with Good Engineering Practices (GEP) and Risk -based Validation approach. This role exists to… more
- Sumitomo Pharma (Raleigh, NC)
- …safety signal management throughout product lifecycle including signal detection, signal validation , signal escalation, development of risk mitigation strategies ... Performs aggregate review of post-marketing safety data in support of safety signal validation , trend detection, risk benefit management, and development of … more
- Truist (Charlotte, NC)
- …analysts focused on model development efforts specific to retail credit risk estimation methodologies. Responsible for the end-to-end development life cycle of ... quantitative models related to the company's management and mitigation of risk . Ensures that model risks are properly identified and managed. Partners across the… 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
- West Pharmaceutical Services (Kinston, NC)
- Associate Process Engineer, Sterilization Requisition ID: 68159 Date: Sep 14, 2025 Location: Kinston, North Carolina, US Department: Operations Description: At ... efforts. **Job Summary** This role is key to developing and introducing process improvements, standards, life cycle management and validation in select… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …environments and regulatory requirements (FDA, EMA, ICH). + Familiarity with process validation principles and CPV. + Strong analytical, problem-solving, ... and compliance of downstream operations through effective technology transfer, validation support, process monitoring, troubleshooting, and lifecycle management… more
- Merck (Wilson, NC)
- …and proven expertise in GMP application and quality systems, particularly in process and equipment qualification & validation , root cause analysis, change ... Devices, Packaging Engineering, Packaging Equipment, Packaging Processes, Pharmaceutical Packaging, Process Optimization, Regulatory Requirements, Risk Management, Root… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …and compliance of upstream operations through effective technology transfer, validation support, process monitoring, troubleshooting, and lifecycle management ... performance, identify trends, and propose process improvements. + Support process characterization and validation activities (PPQ) for upstream processes… more
- Merck (Wilson, NC)
- …(GMP), Management Process , Manufacturing Scale-Up, Mentorship, Packaging Engineering, Process Optimization, Risk Management, Root Cause Analysis (RCA), ... Reporting into the Director, Logistics and Distribution Technology the Associate Director, Logistics and Distribution Technology will be responsible and… more
- Merck (Wilson, NC)
- …lead technical team accountable for rigorous technical outcomes including process qualification and validation , component qualification, specifications, artwork ... Mentorship, New Product Introduction Process , Packaging, Packaging Engineering, Process Optimization, Project Management, Project Planning, Risk Assessments,… more
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