- BeOne Medicines (Pennington, NJ)
- …Strong experience with software lifecycle methodologies, 21CFR Part 11 compliance, and GxP computer systems validation ( CSV ). Previous experience in ... experience in building, configuring, and supporting Quality Assurance and/or Quality Control systems , or Master's Degree in Engineering, Computer Science or… more
- BeOne Medicines (Pennington, NJ)
- …+ Strong experience with software lifecycle methodologies, 21CFR Part 11 compliance, and GxP computer systems validation ( CSV ). + Strong experience with ... and control panel hardware as required by the job. + Experience with computer systems validation practices (GAMP) + MS Project. **Other Qualifications:** +… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …and service providers. + Must have knowledge of software development lifecycle (SDLC) and of computer systems validation ( CSV ) + Experience working in ... biology laboratory quality control process. + Knowledgeable in enterprise level laboratory systems , and quality management concepts that are used in Bio Pharma… more
- Bristol Myers Squibb (Summit, NJ)
- …no better place than here at BMS with our Cell Therapy team. The **Lead Computer System Validation ( CSV ) Engineer** supports the successful implementation of ... full CSV for single and multi-user Computerized Systems . + Develops validation /qualification deliverables such as...technical writing and document development / generation. + Strong computer skills in Microsoft Office Suite - Word, Excel,… more
- Bristol Myers Squibb (Summit, NJ)
- …process automation, and manufacturing environments are preferable* + 5+ years of Computer System Validation ( CSV ) experience in regulated pharmaceutical ... Read more: careers.bms.com/working-with-us . **About the Role** This position will drive computer system validation activities for the Summit site Manufacturing… more
- J&J Family of Companies (Titusville, NJ)
- …activities * In partnership with E&PS own Computer Systems Validation , including writing and driving CSV protocols, Functional Specification (FS), Design ... integrating cross-functional issues. **Preferred:** * Experience with equipment / systems commissioning/qualification/ validation , Process Automation, IT manufacturing … more
- Merck (Rahway, NJ)
- …Quality Assurance community, provide for and lead Quality Assurance oversight for computer system validation matters within the Global Development Quality ... + Endorse and build Quality Management System elements into the end-to-end computer system validation process, thereby promoting permanent inspection readiness.… more
- Lilly (Branchburg, NJ)
- …and upgrading software applications for system management, compliance, and data integrity Partners with Computer System Validation ( CSV ), IT, QC, and QA to ... Design Plan to support configuration management, testing, and Qualification, Validation of proposed systems + Provide lab...initiation and management of change controls related to supported computer systems . Serve as a key resource… more
- ManpowerGroup (New Brunswick, NJ)
- …ERP (SAP), and enterprise quality platforms (Veeva, TrackWise). + Lead compliance and validation efforts ( CSV , Part 11, Annex 11), embedding them into design ... IT to drive the strategy, design, and lifecycle management of digital quality systems within their global manufacturing network. This leader will ensure that Quality… more
- Sokol Materials & Services (Skillman, NJ)
- …DUTIES AND RESPONSIBILITIES * Develop and execute commissioning, qualification, and validation protocols for equipment, facility systems , and utilities, covering ... degree preferred. + Minimum of 3 years of experience in CQV and/or CSV within the pharmaceutical, biotechnology, cell therapy or medical device industries. +… more
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