- Cardinal Health (Trenton, NJ)
- …solutions. You will develop and deploy software code and solutions that comply with FDA computer systems validation methodology. The Medical Segment IT ... the design, development, and deployment of software solutions aligned with FDA computer systems validation (CSV) methodologies. + Define technical… 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
- Sokol Materials & Services (Skillman, NJ)
- …risk-based validation approaches. + Knowledge of regulatory requirements, including FDA , EMA, and ICH guidelines. Knowledge, Skills & Abilities: + Proficient in ... risk-based validation approaches. + Strong analytical, problem-solving, and communication skills....Physical Requirements : + Prolonged periods of sitting and computer use. + Must be able to lift up… 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
- Sokol Materials & Services (Skillman, NJ)
- …focused on utilities and facility qualification. + Strong understanding of validation principles, methodologies, and regulatory requirements, including FDA , EMA, ... ICH guidelines. Knowledge, Skills & Abilities: + Proficient in risk-based validation approaches. + Strong analytical, problem-solving, and communication skills. +… more
- Integra LifeSciences (Princeton, NJ)
- …(ISO 13485) standards is required + Knowledge of 21 CFR Part 11 and Computer /Quality System Software validation is required + Strong oral and written ... in compliance with US and International requirements as defined in FDA Regulations, ISO Standards, European Medical Device Directives, and other International… 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
- BeOne Medicines (Pennington, NJ)
- …intermediates and finished biological products (monoclonal antibodies) under FDA /EU regulations, applicable International Regulations, and BeOne Medicines' processes ... preventive actions (CAPAs). + Participate in transfer and method validation activities, including protocol preparation, protocol execution, and report preparation.… 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