- Lilly (Lebanon, IN)
- … Validation Plan. * Provide subject matter expertise for computer system validation and data integrity for automation systems across the site including: + ... will provide CSV support leading and executing CSV activities for process automation systems across...and non-technical audiences * Knowledge of GMP, regulatory requirements, computer system validation **Basic Requirements:** * Minimum… more
- Bristol Myers Squibb (Summit, NJ)
- …of equipment and full CSV for single and multi-user Computerized Systems . + Develops validation /qualification deliverables such as Validation Plans, ... their personal lives. Read more: careers.bms.com/working-with-us . **Summary:** The Manager, CSV Equipment and Instrumentation - Cell Therapy supports the successful… more
- J&J Family of Companies (Santa Clara, CA)
- …NPS CSV provided Quality Assurance oversight for non-product software systems used in GxP regulated environments including systems supporting Manufacturing, ... risk-based validation , and Quality System expectations related to digital systems . **Qualifications** : + Minimum 6 years of experience in Quality Assurance… more
- Mentor Technical Group (NC)
- …for the development and execution of Computer System Validation ( CSV ) and Decommissioning deliverables for Laboratory Equipment/ Systems . + Acts as the ... is required. + Knowledge of SDLC regulations, including 21CFR part 11, computer systems validation requirements. + Must have experience in configuring… more
- Lilly (Indianapolis, IN)
- …their assigned functional areas, projects and/or systems comply with corporate computer system validation ( CSV ) standards. This includes providing ... Systems Standards, Practices, and Procedures, providing oversight for CSV execution (including approving CSV documents per...systems development life cycle + Proficiency with Lilly Computer Systems Validation and demonstrated… more
- Lilly (Indianapolis, IN)
- …their assigned functional areas, projects and/or systems comply with corporate computer system validation ( CSV ) standards. This includes providing ... Systems Standards, Practices, and Procedures, providing oversight for CSV execution (including approving CSV documents per...+ Proficiency with Microsoft Office products + Experience with Computer Systems Validation + Prior… more
- PCI Pharma Services (Bedford, NH)
- …team. In this role, you'll take the lead in developing and executing validation strategies for GxP computer systems -ensuring everything from equipment ... shape the future of PCI. We're looking for a ** CSV Validation Engineer III** to join our...regulatory and performance standards. **What You'll Do:** + Lead validation activities throughout the computer system lifecycle-including… more
- Astellas Pharma (South San Francisco, CA)
- … Validation Engineer plans and executes risk-based qualification and computerized systems validation activities in cell and gene therapy research environments ... and Qualification Lifecycle** + Plan and execute risk-based CSV for research computerized systems and instrument-connected... Science, Life Sciences. + 8+ years of Computerized Systems Validation experience with hands-on authorship and… more
- Jabil (Hunt Valley, MD)
- … activities, including validation of facilities, utilities, equipment, cleaning, computer systems and process in compliance with global regulatory ... teams. + Provide oversight and strategic direction for the Computer System Validation ( CSV ) program...for cGMP manufacturing. + Demonstrate SME-level knowledge of process/equipment validation , computer systems , standards, and… more
- PACIV (Indianapolis, IN)
- …completion action items for any deficiencies resulting from Periodic Reviews. + Update Computer System Validation ( CSV ) documentation which may include ... environment. This role is responsible for executing and managing periodic reviews of computer systems , and driving resulting action items to completion.. The… more