- Unither Pharmaceuticals (Rochester, NY)
- …Specifications, Functional and Design Specifications. If completed by an external company, the computer systems validation ( CSV ) specialist will be ... Computer Systems Validation Specialist Who we are? We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that… more
- Regeneron Pharmaceuticals (Troy, NY)
- …Specialist would also plan, coordinate and participate in compliant computer system validation ( CSV ) process for systems which require formal ... are hiring a Principal QA Validation Specialist to support validation and qualification of computer systems within IOPS. The Principal QA Validation … more
- Curia (Albany, NY)
- …contributions + Learning platform + And more! Responsibilities Computer Systems Validation + Manage multiple site and global CSV projects at any time + ... CSV Systems Engineer II/III in Albany,...field + Minimum 3 years' experience in quality and computer systems validation and/or information… more
- Cognizant (Boston, MA)
- … to guarantee seamless integration across platforms and systems . + Manage Computer System Validation ( CSV ) activities in alignment with global regulatory ... will make an impact by leading the testing and validation strategy for enterprise-level Document Management Systems ...and validation strategy for enterprise-level Document Management Systems (DMS) within the Life Sciences domain. You will… more
- NTT DATA North America (Pittsburgh, PA)
- …workflows. Experienced in delivering projects in regulated environments, ensuring compliance with FDA Computer Systems Validation ( CSV ) and quality ... accountability and communication structures. Required Qualifications Bachelor's degree in Computer Science, Information Systems , Business, or related field.… more
- PACIV (San Juan, PR)
- …Sets: + Strong DeltaV programming skills (especially batch processes). + Experience with computer systems validation ( CSV ) in regulated/GMP environments. ... including technical assessments and cost estimates. + Develop, review, and approve CSV documentation. + Ensure validation and compliance with policies, quality… more
- Lilly (Indianapolis, IN)
- …efforts. + Influence and oversee Commissioning and Qualification (C&Q) and Computer Systems + Validation ( CSV ) of GMP assets including review and ... in a cGMP facility + Prior experience in C&Q, CSQ, and/or CSV + Proficient with computer systems including Microsoft Office, electronic document management … more
- Lilly (Indianapolis, IN)
- …Proficient in establishment and maintenance of GMP or CS mode analytical equipment, to include computer systems validation ( CSV ). + Proven ability to ... and release of data including data released from CM, stability, process validation , and reference standard characterization. + Utilizes technical skills to lead or… more
- Teva Pharmaceuticals (West Chester, PA)
- …+ Involved in implementation of new releases, upgrades and changes in accordance with Computer Systems Validation ( CSV ) standards. + Perform day-to-day ... to Software Development Life Cycle (SDLC) phases for laboratory computer systems . Ensures that system implementations are...+ Minimum 3 years of experience working in a validation analyst or similar role, preferably within the pharmaceutical… more
- Catalent Pharma Solutions (Kansas City, MO)
- **Senior Validation Specialist I, BioAnalytics Computer System Validation ( CSV ) & Compliance** **Position Summary:** Catalent, Inc. is a leading global ... Specialist is primarily responsible for leading, implementing and managing Computer System Validation ( CSV ) and...information systems + Author, review and approve CSV , DI and Validation related documents and… more
- 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