- Insmed Incorporated (NJ)
- …with Veeva QualityDocs /QMS is preferred.Knowledge and understanding of the FDA Computer Software Assurance (CSA) fundamental concepts.Basic understanding of ... Who You Are:3+ years' hands on experience in a validation role with responsibility for computer systems...processes is preferred.Solid working knowledge of CSV guidelines and FDA /EU regulations: 21 CFR Part 11, Annex 11, GAMP… more
- Merck & Co. (Rahway, NJ)
- …of product design and development; manufacturing process development, qualification, and validation ; and design control and risk management techniques to positively ... development programs ranging from concept generation/selection, development, verification, and validation to launch readiness:Lead the cross-functional Device Working Groups… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …strongly preferred.Experience with Manufacturing Execution Systems (MES) design/development and validation is preferred.Experience with Computer System ... manufacturing and protocol-driven activities such as tech transfer and process validation .Assist in the development of process, operational, and quality improvements… more
- Cipla (Fall River, MA)
- …controlled documents to ensure compliance with GMP, GDP, and regulatory standards such as FDA 21 CFR Part 11, ICH, and ISO. This role supports the Quality Management ... approved and executed documents related to SOPs, batch records, validation and qualification protocols, specifications, training records, QMS related documents,… more
- Cipla (Central Islip, NY)
- …Controls, Technical Deviations, Methods, Specifications, COAs, Batch Records, Validation protocols/reports. Conduct focused time-studies to support packaging ... investigations, Corrective Action Preventive Actions (CAPAs), change controls and validation activities as required. Apply complete knowledge of process improvement… more
- Twist BioScience (South San Francisco, CA)
- …teams.Work with test engineers to develop and execute verification and validation protocols to ensure software reliability and compliance.Support automated and ... and user manuals.Ensure software complies with applicable regulatory standards (eg, FDA , ISO 13485, if applicable).Contribute to research and development efforts for… 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)
- …Controlled environment monitoring Water system monitoring Bacterial endotoxin test method validation and monitoring Bioburden test method validation and ... validation and dose audit management Ethylene oxide sterilization validation and requalification Reprocessible device cleaning and sterilization validation … more
- PCI Pharma Services (Rockford, IL)
- …for planning, developing, implementing and monitoring the equipment and process validation strategy for PCI's Advanced Drug Delivery business. The QE will ... design/tech transfer with NPI by directly supporting or driving validation processes with appropriate risk management leadership. As the...of at least three years of experience in an FDA regulated industry with strong preference to medical device… more
- Merck (West Point, PA)
- …of product design and development; manufacturing process development, qualification, and validation ; and design control and risk management techniques to positively ... development programs ranging from concept generation/selection, development, verification, and validation to launch readiness: Lead the cross-functional Device Working… more
