- 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
- 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
- Cardinal Health (Augusta, ME)
- …+ Lead the design, development, and deployment of software solutions aligned with FDA computer systems validation ( CSV ) methodologies. + Define technical ... You will develop and deploy software code and solutions that comply with FDA computer systems validation methodology. The Medical Segment IT Product team… 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
- J&J Family of Companies (Raritan, NJ)
- …in accordance with J&J's Systems Development Life Cycle (SDLC) and Computer System Validation ( CSV ) Framework, assuring compliance across the ... Description:** Johnson and Johnson is recruiting for an **Enterprise Quality R&D Clinical Computer System Validation ( CSV ) Manager** , located in either… 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
- Lilly (Lebanon, IN)
- … systems . **How You'll Succeed:** + Provide oversight and support of computer systems validation activities, including the review and approval of ... process to validate, maintain and retire new and existing computer systems . The position will be responsible...all documentation issued to support the validation /qualification of non-GMP and GMP systems , as… 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
- Fujifilm (Holly Springs, NC)
- …https://www.fujifilm.com/us/en/about/region/careers **Job Description** **What You'll Do** + Ensures that Computer System Validation is performed to a ... **Position Overview** The Automation Engineer 2, CSV will provide support to the Drug Substance...the change control process + Helps to maintain the validation status of DSM Automation Computerized Systems … more
- Bristol Myers Squibb (Summit, NJ)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . The **Lead Computer System Validation ( CSV ) Engineer** supports the successful ... 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
- 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
- Jabil (Hunt Valley, MD)
- …and cGMP, are addressed in validation + Perform Risk Assessments of the CSV systems with an understanding of applying risk management principles. + Review ... across cross-functional teams. This individual will be responsible for overseeing Computer System Validation ( CSV ) activities, ensuring compliance… 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
- 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
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