- Sumitomo Pharma (Trenton, NJ)
- …drug/device combination products) is required. Must be familiar with EMA and FDA validation requirements, including Lifecycle Model. Lean Six Sigma ... and experienced individual for the position of **Director, Commercial Manufacturing Validation ** . This role functions within SMPA's Global Technology and Quality… more
- BeOne Medicines (Pennington, NJ)
- …and release of material, intermediates and finished products under FDA /EU regulations, applicable International Regulations, BeOne processes and procedures. ... Biochemistry laboratory routine operations, including but not limited to validation , SOP revisions, specification updates, testing records, personnel training and,… more
- Integra LifeSciences (Princeton, NJ)
- …environment monitoring + Water system monitoring + Bacterial endotoxin test method validation and monitoring + Bioburden test method validation and monitoring ... validation and dose audit management + Ethylene oxide sterilization validation and requalification + Reprocessible device cleaning and sterilization validation… more
- Bristol Myers Squibb (Summit, NJ)
- …vendors. Experience with technical writing and document development / generation + Strong computer skills in Microsoft Office Suite - Word, Excel, Visio and Outlook, ... + BS degree or equivalent experience + Minimum 5 years of experience in FDA -regulated industry with at least 2 years of recent hands-on CSV and implementation… more
- Oracle (Trenton, NJ)
- …applying medical device standards (including IEC 62304, IEC 82304, and FDA guidance), define software interfaces, manage traceability across the system lifecycle, ... device software, ensuring vulnerability management and cybersecurity compliance with FDA and global regulatory expectations. + Apply the organization's Risk-Based… more
- BeOne Medicines (Pennington, NJ)
- …and release of materials, intermediates and finished products under FDA /EU regulations, applicable International Regulations, BeOne processes and procedures. ... Physicochemistry laboratory routine operations, including but not limited to validation , SOPs, specifications, testing records, personnel training and assessment,… more
- NTT DATA North America (Mahwah, NJ)
- …automation solutions + Build and enhance Excel-based tools for data processing, validation , and reporting + Refactor and optimize existing VBA code for performance ... and compliance standards + Produce and maintain technical and validation documentation + Collaborate with business users to gather...Skills + Medical Device domain experience: + Exposure to FDA regulations, ISO 13485, or 21 CFR Part 11… more
- BeOne Medicines (Pennington, NJ)
- …descriptions, control strategies, and campaign summary reports. + Author Process validation plan, PPQ protocols, and various upstream study protocols to support ... / Development. + Knowledge of biopharmaceutical equipment qualification and Validation activities. + Cell culture knowledge including inoculum processes, bioreactor… more
- Integra LifeSciences (Princeton, NJ)
- …microbiology, manufacturing facility engineering and design, statistical analysis, process validation , regulatory compliance, clinical trials, computer systems ... CE-marked medical devices. + Experience working for regulatory agencies (such as US FDA , MHRA, TGA, Health Canada, SFDA, ANVISA, US state, etc.) or Notified Bodies… more
- Integra LifeSciences (Princeton, NJ)
- …+ Participate in design and change control activities. + Participate in FDA inspections, ISO Certification and Surveillance audits and Internal audits. + Collaborate ... product development, product realization, design transfer, design verification and validation . + Experience leading engineering product development teams, experience… more