- BD (Becton, Dickinson and Company) (Zelienople, PA)
- …modeling a plus. + Familiarity with FDA regulatory requirements, GMP, ISO, lean, process validation and six sigma methodologies. + Position requires good logic ... + Responsible for creation/update of PFMEA/Risk analysis. + Identify need for validation of manufacturing equipment/ process and support systems to meet product… more
- Takeda Pharmaceuticals (Lexington, MA)
- …products. This key technical role is responsible for change controls, manufacturing process validation , device product complaints, regular review of DHF, and ... By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- …functions in establishing product specifications, stability programs, material qualification, method validation , method transfer, and process validation . ... for a range of pharmaceutical dosage forms to support formulation, process , and specification development. This position collaborates with product development… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- …input, design output, specification development, test method development, design verification/ validation , process validation , design transfer, and risk ... web-based software for various applications. * Knowledge and understanding of IQ/OQ/PQ process , validation of assembly, processing, and analytical test equipment… more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- …and problem investigation. + Review analytical development report, assay and process validation report and other technical documents for technical ... Department. This position performs assay development, characterization, optimization, transfer, validation , and investigations for QC. You would provide technical… more
- BeOne Medicines (Pennington, NJ)
- …guidance into site processes and systems including optimization & digitalization of the validation process . + Responsible for maintenance of the Computer System ... will serve as the technical expert and lead for Computer System Validation /Computer System Assurance, (CSV/CSA) Data Integrity & IT Compliance for IT Systems.… more
- JBT Corporation (Lakeland, FL)
- …services. You will report to the Senior Manager of Innovation. + Provide Process Authority validation and support services for aseptic processing and filing ... biological validation studies. + Perform compliance audits, facility audits, process design and optimization, product/ process assessments. + Teach courses on… more
- Amentum (Indian Springs, NV)
- …(R-40), SDR Process , Document Control Listing (R-59), record reversal process , warehouse validation (Inventory Prep) Zero Balance/Zero Demand DOLT>30 Days, ... After Hours Degraded Ops Files Delivery, Reject Management Listing (D818), Process Receipts, RSP Storage & Maintenance, RSP/MSK Deployment/Transfer Process ,… more
- Lilly (Indianapolis, IN)
- …site. + Lead and/or support the development and execution of FAT, commissioning and validation of equipment and process workflows in alignment with TS/MS and ... or radiopharmaceutical drug products preferred + Proficient in qualification and validation requirements for manufacturing equipment and process changes +… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …files. + Ensure the effective transfer of design to manufacturing, including process validation , DHF completeness, and production control plans. + Participate ... and sustaining engineering projects, ensuring quality is built into the design process . + Oversee the generation and review of design input requirements, design… more