- Corning Incorporated (Durham, NC)
- …(ISO 11737, ISO 11138, ISO 14161, ISO 10993) required to support sterilization process validation + Experience working with data analysis software (JMP, Minitab, ... Sterilization Process Engineer **Date:** Apr 28, 2025 **Location:** Durham,...sterilization + Supporting and executing activities related to development, validation , routine sterilization and requalification activities + Lead and… more
- Fujifilm (Holly Springs, NC)
- …Practice (CGMP) regulated facility * Ensures consistent high standards in equipment and process validation to meet quality objectives on time * Provides QA ... on spearheading quality oversight for Drug Substance Manufacturing processes and managing validation documentation to ensure the highest standards are met. This role… more
- Astrix Technology (Raleigh, 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
- Fujifilm (Holly Springs, NC)
- …new manufacturing documents in support of TT e. Supports and approves of process validation protocols and documentation (PPQ, process -specific cleaning ... This position interacts cross-functionally with Manufacturing, Supply Chain, Quality Control, Process Sciences, Validation , and various Client functions to… more
- Fujifilm (Holly Springs, NC)
- …associated support functions such as Process Science, Engineering Science, Process Engineering, Validation , and Automation + Ensures the quality assurance ... standards + Approves critical lifecycle documentation, including risk assessments, product/ process /equipment specifications, functional specifications,traceability matrices, qualification protocols, validation… more
- Insight Global (Browns Summit, NC)
- …will be directly supporting a large project and initiative for change management, process control & improvement, validation reporting, and program process ... Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ . Skills and Requirements * Process Improvement, Change Management, and Validation experience.… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …in Lab & Manufacturing Operation (Injectable), Product Development, Technology Transfer, Process Validation , Cleaning Validation and Investigations ... Fishbone diagram, -5 WHY- Analysis, IS - IS NOT Analysis, Peeling the Onion, Process Mapping / Flow Charts, Interviews and brain storming + Reviewing the adequacy of… more
- Merck (Raleigh, NC)
- … process scale up, technology transfer to internal and external sites, process validation , authoring of regulatory submissions and support of significant ... the Sterile Drug Product Commercialization (SDPC) group provides the technical process leadership and laboratory capabilities for late stage and commercial drug… more
- J&J Family of Companies (Wilson, NC)
- …Engineer for Johnson & Johnson Innovative Medicine is responsible for developing a process for and performing of validation of computer and/or automation systems ... Honeywell BAS software, FAT and SAT protocols/reports. + Develop a process for the validation of computer and automation systems ensuring compliance to required… more
- Fujifilm (Holly Springs, NC)
- …transfer (TT) across multiple unit operation + Coordinates, plans, and executes manufacturing process validation runs + Supports design and leads generation of ... sampling plans for process validation reports (PVRs) and investigations + Writes and reviews master batch records (MBRs) and standard operating procedures… more