- Actalent (East Windsor, NJ)
- …Control and Analytical Development. + Develop and update analytical test reports, validation protocols (IQ/OQ/PQ), and stability study reports. + Prepare method ... validation protocol/reports, method transfer protocol/reports, and technical documents including...with industry best practices, regulatory changes, and advancements in pharmaceutical quality control. Essential Skills + 4-5 years of… more
- Cytel (Trenton, NJ)
- …to do the same. **Sponsor-dedicated:** Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at ... As a Biostatistician you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment,… more
- J&J Family of Companies (Raritan, NJ)
- …maintaining project progress and design issues + Strong experience in computer systems validation in GxP environments in the pharmaceutical industry required + ... solutions for J&J. TQ&C is the Subject Matter Expert (SME) for validation /qualification of both applications and infrastructure in accordance with J&J's Systems… more
- Integra LifeSciences (Princeton, NJ)
- …including product disposition, manufacturing instructions, change controls, and process validation documentation. + Monitor quality performance of the ExM sites ... or associated scientific discipline. + Minimum 5 years Medical Devices or Pharmaceutical experience in Quality or R&D Engineering position. + DMAIC experience +… more
- Integra LifeSciences (Princeton, NJ)
- …integration of Trackwise platform within the Integra IS landscape. * Creating validation deliverables such as test scripts, URS documents, FRS and Configuration ... Specification documentation following Integra's Computer System Validation and Change control process to maintain the system in a validated state. To perform this… more
- BeOne Medicines (Pennington, NJ)
- …Manager requires rich technical experience in construction project management for pharmaceutical production facility and ability to manage projects and ensure ... highly desirable. + Special knowledge requirements include biopharmaceutical and pharmaceutical processes and facility design approaches, plus a solid understanding… more
- PSKW LLC dba ConnectiveRx LLC (Whippany, NJ)
- …has become increasingly complex. When things get messy along the prescription journey, pharmaceutical manufacturers rely on us to untangle the process and create a ... are responsible for overseeing all aspects of program data collection, cleaning, validation , and delivery to our customers. Comprehensive knowledge of the field's… more
- Merck (Rahway, NJ)
- …safe and robust manufacturing processes through process characterization, technology transfer, validation , filing and supply support of late-stage projects in the ... **Required Experience and Skills:** Relevant work experience in chemical, pharmaceutical , large molecule, or vaccine process development, including the following:… more
- Sanofi Group (Morristown, NJ)
- …batch data processing, real-time API integration, and regulatory compliance for pharmaceutical or healthcare systems. The role ensures that our REMS (risk ... teams to ensure that all integration processes adhere to the required validation protocols for FDA-compliant systems. Provide documentation and support for system … more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …robust and compliant manufacturing processes through effective technology transfer, validation , process monitoring, and lifecycle management. This individual will ... transfer activities to new or existing CDMOs. + Oversee the process validation lifecycle (PPQ, CPV, etc.) ensuring compliance with global regulatory standards. +… more