- United Therapeutics (Research Triangle Park, NC)
- …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... third party contract laboratories as applicable + Plan and execute method validation protocols for API, intermediates, drug substance, and drug product release and… more
- Philips (Cambridge, MA)
- …in information technology engineering or computer science. + Strong understanding of FDA validation , ITIL processes, and regulatory compliance. + You must be ... and IT performance optimization projects. + Ensure all solutions comply with FDA validation and regulatory requirements. + Monitor and report on key performance… more
- Curia (Albany, NY)
- …the operational excellence; * Establish and maintain an efficient and compliant validation program including computer software validation and instrument ... well as the review of SOPs, investigations, specifications, methods, validation reports, and analytical reports; * Along with the...instruments, such as UV-VIS, UPLC, and HPLC; and * FDA and Good Manufacturing Practice (GMP) regulations. OR A… more
- Mallinckrodt Pharmaceuticals (Webster Groves, MO)
- …+ Product release and investigations + Change Management and CAPA + FDA inspections / Regulatory Affairs + Validation Skills/Competencies: + Self-motivated ... (batch records, methods, labels, etc ) + Facility/Equipment Qualification and validation (process/cleaning) + Stability data review / stability coordination + CAPA… more
- Amazon (Bellevue, WA)
- …(eg, Pharmaceutical, Medical Devices, Food & Beverage) with understanding of GMP, FDA , or similar compliance requirements for systems validation . Amazon is ... protocols for Manufacturing Execution System (MES) applications, ensuring robust validation of functionality, performance, and integration before production deployment.… more
- Stryker (Redmond, WA)
- …on PCBA (Printed Circuit Board Assembly) design, manufacturing, testing, and validation . + Development and execution of product testing requirements and ... specifications, including design for testability and testing validation plans. + Conduct evaluations of testability and coverage for ICT (In-Circuit Testing) and FCT… more
- BeOne Medicines (San Carlos, CA)
- …join our Clinical Biomarker laboratory. This role will lead the development, validation , and execution of quantitative and qualitative mass spectrometry assays to ... well as hands-on experience in mass spectrometry-based biomarker method development, validation and clinical sample analysis. **Essential Functions of the job:** +… more
- Sanofi Group (Swiftwater, PA)
- …and technical support to the company for project planning, process, systems and computer validation , aseptic processes and validation , component/ product ... compliance policies and systems + Supply chain performance, related testing, validation , computer systems, quality systems, training, product assessment,… more
- BeOne Medicines (Pennington, NJ)
- …site drug product MST function to support technology transfer, validation , continued process verification, investigations, change management and manufacturing ... CPV program for process performance + Responsible for technical transfer, validation , investigation, and technical support of aseptic manufacturing operations in… more
- AbbVie (Worcester, MA)
- …Historian systems. + Ensure all automation systems comply with regulatory requirements ( FDA , cGMP, etc.). + Mitigates risk within functions through sound design, ... of automation systems. + Maintain documentation including functional specification, validation protocols and change controls. + Experience in change control,… more