- Pfizer (Bothell, WA)
- …of processes/procedures defined in the system development lifecycle (SDLC) and Computer Systems Validation (CSV) + Lead development of risk-based ... team. As a Senior Specialist, Digital / CSV ( computer system validation ) and...cycle in a regulated environment with responsibility to ensure systems are compliant with FDA and global… more
- West Pharmaceutical Services (Scottsdale, AZ)
- Senior Engineer, Quality Systems Requisition ID: 71326 Date: Sep 9, 2025 Location: Scottsdale, Arizona, US Department: Quality Description: **This is an Onsite role ... through our sustainability efforts. **Job Summary** Sr. Engineer, Quality Systems supports and executes the effective development, implementation, and continuity… more
- Lilly (Branchburg, NJ)
- …software applications for system management, compliance, and data integrity Partners with Computer System Validation (CSV), IT, QC, and QA to ensure ... Assists in the selection, implementation, and maintenance of computerized systems . Authors and reviews computer system...management, testing, and Qualification, Validation of proposed systems + Provide lab management and system … more
- Lilly (Branchburg, NJ)
- …Camstar, or Werum PAS-X). + Minimum 3+ years experience leading or supporting the Computer System Validation of IT platforms including Data Integrity ... and manage multiple tasks simultaneously. * Experience with Computer System Validations. * Experience with Manufacturing Execution Systems and how… more
- Lilly (Branchburg, NJ)
- …operations. Execute with precision, speed, and simplicity, ensuring compliance with Computer Systems Validation policies, standards, procedures, and ... assessment of all cGXPsystems and dashboards, ensuring that all validation requirements have been met prior to system...pharmaceutical regulations (eg cGMP's, 21 CFR Part 11, Computers Systems FDA ) and other applicable regulations (eg… more
- Cook Medical (Pittsburgh, PA)
- …and various reviews meetings supporting solution delivery.* Execute commissioning; supports computer system validation team's installation qualification ... for operational ownership ofapplications and/or business intelligence solutions on computer systems providing business/IT or manufacturing support (ie… more
- Fujifilm (College Station, TX)
- …of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures with ... experience in pharmaceutical, biotechnology, or related industry, preferably in FDA -regulated environments, OR; + Bachelor's Degree and 7+ years...in computerized systems validation . + Computer System Validation experience with… more
- United Therapeutics (Research Triangle Park, NC)
- …approve cGxP related documents (ie, product/ design specifications, computerized systems , validation protocols and reports (IOQ/PQ), analytical/microbiological ... manage and prioritize workloads, stressful situations, and deadlines + Demonstrated expertise with FDA Quality System regulations and cGMP, ISO 13485, ISO 14971,… more
- Edwards Lifesciences (Irvine, CA)
- …+ Experience with FDA guidelines for Software Quality and Systems Validation required + Experience with Good Manufacturing/Good Documentation Practices ... by Leadership **What you'll need:** + Bachelor's degree in computer science or related field + 4 years of...with FDA guidelines for Software Quality and Systems Validation is a plus + Substantial… more
- Bio-Techne (Minneapolis, MN)
- …with relevant regulatory requirements ( FDA , EMA, ISO, etc.) + Oversee system validation processes in accordance industry standards + Implement robust data ... and advanced manufacturing analytics + Understanding of GxP regulations and computerized system validation requirements + Working knowledge of data management,… more
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