- Fujifilm (Holly Springs, NC)
- …is the Subject Matter Expert (SME) and leads tasks associated with Computer System Validation (CSV). This role provides input and determine action items 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
- J&J Family of Companies (Wilson, NC)
- …Wilson, North Carolina. We are responsible for Process, Thermal & Cleaning Validation , Standardization of Equipment for New Product Introduction, and Life Cycle ... for an MSAT Engineer- Thermal to join our MSAT Validation team ; located in Wilson, NC! **Position Summary:**...knowledge and application of industry regulations including those of FDA , HPRA, EMEA and other authorities. + Excellent verbal… more
- ThermoFisher Scientific (Greenville, NC)
- …meticulous QA Engineer III to join our Quality Assurance team as a Quality Validation Specialist. The ideal candidate will have a strong background in quality ... validation processes, excellent analytical skills, and a dedication to...Familiarity with relevant industry standards and regulations (eg, ISO, FDA , GMP) is highly desirable. + **Certifications** : Relevant… more
- Fujifilm (Holly Springs, NC)
- …and qualification of equipment and systems for the site. This role performs validation activities to include but not limited to equipment set up, building ... validated per standards and regulatory requirements (eg, Food & Drug Administration ( FDA )) * Reads piping & instrumentation diagrams (P&IDs) to walkthrough systems… more
- Fujifilm (Holly Springs, NC)
- …Substance Operations. In this role, you will oversee our Quality Product and Validation teams, along with the batch review and release teams. Your responsibilities ... including the Batch Review and Release teams and the Quality Engineering/ Validation team, ensuring alignment with organizational goals and regulatory requirements +… more
- Perdue Farms, Inc. (Lewiston Woodville, NC)
- …interface with internal, external, customer and regulatory (USDA and/or FDA where applicable) inspectors regarding sanitation related non-conformance reports and ... + Sanitation Standard Operating Procedures (SSOP) + Monitoring Verification and Validation of the Cleaning Process (ATP, Indicators, Pathogens, Allergens, Adjacent… more
- Merck (Wilson, NC)
- …high liability to projects of varying scopes. Expertise in qualification and process validation practices for complex systems is essential to success in this role. ... support for equipment design, equipment qualification, process demonstration, and process validation . + Responsible for managing capital and expense projects for… more
- Fujifilm (Holly Springs, NC)
- …and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports * ... Generates, reviews, and approves QA procedures for the validation approach and lifecycle documents for Manufacturing Systems * Generates, reviews, and approves QA… more
- Fujifilm (Durham, NC)
- …skills with a focus on preventive and corrective actions. + Proficiency in validation documentation and regulatory standards (eg, FDA , EMA). + Familiarity with ... The role will serve as the system owner for FDB's electronic validation lifecycle management system. The Vice President of Commissioning, Qualification and Ops… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …working a 2-2-3 rotation schedule. This position is in a fast-paced, FDA regulated environment in the Medical Devices/Diagnostics Industry. The QC Biochemistry ... with LIMS data entry to support LIMS maintenance and validation activities. + Assists with revisions to QC department...Experience participating in the management of regulatory audits (ie FDA , MDSAP, ISO, OSHA, EPA, etc.). + Experience in… more