- Sanofi Group (Swiftwater, PA)
- …+ Provide guidance and technical support to the company for project planning, process, systems and computer validation , aseptic processes and validation , ... distribution & audit. + Lead the site's **quality management system ** to ensure continuous compliance and certification. Ensure the... systems + Supply chain performance, related testing, validation , computer systems , quality … more
- Bristol Myers Squibb (Devens, MA)
- …in biologics or cell therapy manufacturing. + Strong understanding of CSV ( computer system validation ), data integrity, and regulatory requirements ... within the Cell Therapy Facility, including requirements gathering, design, implementation, validation , and ongoing support. + Oversee system integration with… more
- Quality Consulting Group (Juncos, PR)
- …tools, techniques, and methodologies. + Provides or directs verification and validation of software system requirements, traceability, and testability. + ... Organization and Communication skills + Technical writing knowledge + Knowledge of Process validation and Computer software validation (eg requirements flow… more
- Actalent (Colonie, NY)
- …with Good Practice (GxP) guidelines (eg, GMP, GCP as applicable). Hands-on experience with Computer System Validation (CSV) practices in alignment with GAMP5 ... you. Essential Skills + Education & Certification: Bachelor's degree in Information Systems , Computer Science, Engineering or a related field. PMP certification… more
- J&J Family of Companies (Raritan, NJ)
- …cell therapy industries + Basic IT Knowledge + Knowledge or experience with CSV ( Computer System Validation ). + Hands-on experience with HVAC controls ... control system software, field devices, instrumentation, and system validation (CSV) is highly desirable. +...systems in cleanroom environments and ability to support system qualification/ validation **Other:** + May require up… more
- Fujifilm (Holly Springs, NC)
- …Visit: https://www.fujifilm.com/us/en/about/region/careers **Job Description** **What You'll Do** + Ensures that Computer System Validation is performed to a ... summary reports) + Helps to assess the impact of Computer System modifications through the change control...the change control process + Helps to maintain the validation status of DSM Automation Computerized Systems … more
- J&J Family of Companies (Anasco, PR)
- …and machine programs to support tasks associated with process validation (Installation Qualification, Operation Qualification, Performance Qualification, Computer ... systems , manufacturing equipment, etc. is required. + Knowledge in computerized systems . Demonstrates strong computer skills, such as the use of Microsoft… more
- Genentech (Hillsboro, OR)
- …maintenance, validation , and decommissioning of the DeltaV DCS platform. Lead Computer System Validation (CSV) efforts, including validation ... highly automated pharmaceutical drug substance facility. The site employs highly integrated computer control systems to manage plant operations and manufacturing… more
- Amgen (Washington, DC)
- …including contract negotiation and performance oversight. + Hands-on experience with computer system validation processes and documentation, including ... IS professionals managing regulatory systems and services. + Oversee system validation , configuration management, access controls, and end-user support… more
- Catalent Pharma Solutions (Kansas City, MO)
- …+ Work closely with Catalent Quality, Operations, and Validation to deliver Computer System Validation (CSV) projects and support tasks involving ... + Identifies and implements improvement opportunities for Laboratory, Manufacturing and Enterprise computer systems + All other duties as assigned **The… more
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