- Aequor (Davie, FL)
- …o Ensure systems meet GxP, FDA, and ISO standards through robust Computer Systems Validation ( CSV ) and documentation practices. Cross-Functional ... lead and support cross-functional initiatives across IT, OT, and controls systems in a GMP-regulated pharmaceutical manufacturing environment. This role will drive… more
- Insmed Incorporated (San Diego, CA)
- …partners.ResponsibilitiesEDC System Design & Development:Lead the setup, development, and validation of EDC systems , including configuration settings, ... ICH-GCP) and company SOPsPerform user acceptance testing (UAT) and validation of EDC systems to ensure data...CSV , CQA, other) to maintain compliance with EDC systems and associated applicationsSupport audits and inspections by providing… more
- J&J Family of Companies (Wilson, NC)
- …applicable points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation ( CSV ) and Lifecycle ... Site Engineering Group located in Wilson, NC site. This role will be part of our computer system validation team for Wilson, NC site. At Johnson & Johnson, we… more
- Fujifilm (College Station, TX)
- …applicable points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation ( CSV ) and Lifecycle ... **Position Overview** The Manager, CSV will be responsible for management, scheduling, and...engineering principles. + Working knowledge and expertise in computerized systems validation . + Computer System… more
- 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
- Lilly (Indianapolis, IN)
- …includes providing consulting and interpretation of policies and procedures, providing oversight for computer systems validation ( CSV ) and platform ... or equivalent experience (eg, 4+ years' experience in IT, Automation, or computer systems validation . + Proficiency in cloud-based technologies + Proficiency… more
- Lilly (Indianapolis, IN)
- …with local business partners to influence and oversee the Commissioning and Qualification (C&Q) and Computer Systems Validation ( CSV ) of new and existing ... systems used within the Foundry are compliant with current computer systems validation expectations. This will include coordinating with the Foundry QA… more
- Caris Life Sciences (Irving, TX)
- …and incorporations of software industry best practices. Guides software development project teams as a Computer Systems Validation ( CSV ) and Computer ... practices are incorporated throughout the software development process. The scope of CSV /CSA includes computerized systems and software tools (used to support… 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
- BeOne Medicines (Pennington, NJ)
- …Strong experience with software lifecycle methodologies, 21CFR Part 11 compliance, and GxP computer systems validation ( CSV ). Previous experience in ... experience in building, configuring, and supporting Quality Assurance and/or Quality Control systems , or Master's Degree in Engineering, Computer Science or… more
- BeOne Medicines (Pennington, NJ)
- …+ Strong experience with software lifecycle methodologies, 21CFR Part 11 compliance, and GxP computer systems validation ( CSV ). + Strong experience with ... and control panel hardware as required by the job. + Experience with computer systems validation practices (GAMP) + MS Project. **Other Qualifications:** +… more
- Bristol Myers Squibb (Devens, MA)
- …. **Summary:** We are seeking a highly skilled and motivated Senior Engineer - IT Computer System Validation ( CSV ) to join our team at the Devens ... . **Key Responsibilities:** + Gain a thorough understanding of computer systems deployed at Devens CTF. +...quality assurance, validation , or compliance for computerized systems . + Knowledge of CSV principles, GAMP… more
- Sanofi Group (Swiftwater, PA)
- **Job Title:** Computerized Systems Validation Engineer ( CSV ) Engineer **Location** : Swiftwater, PA **About the Job** We deliver 4.3 billion healthcare ... directly the manufacturing system automation computer system validation . As a Computerized Systems Validation... Engineer will be responsible for ensuring all Computerized Systems Validation ( CSV ) lifecycle activities… 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
- Bristol Myers Squibb (New Brunswick, NJ)
- …and service providers. + Must have knowledge of software development lifecycle (SDLC) and of computer systems validation ( CSV ) + Experience working in ... biology laboratory quality control process. + Knowledgeable in enterprise level laboratory systems , and quality management concepts that are used in Bio Pharma… more
- Curia (Rensselaer, NY)
- Senior QA Validation Specialist - CSV Systems Engineer Summary: The Senior Validation Specialist, assists with the validation activities throughout ... validation areas (Equipment qualification, packaging, cleaning, utilities, process or computer validation ) + Expert in cGMP documentation practices Physical… more
- PACIV (San Juan, PR)
- …solutions servicing the Life Sciences sector, is looking for a Computerized System Validation ( CSV ) Specialist/Engineer IT Systems , for its Puerto Rico ... office. Job Description: The Computerized System Validation ( CSV ) Specialist/Engineer will be responsible for...Education: Bachelor's degree in Engineering or related science studies ( Computer Systems or Engineering preferred). + Minimum… more
- Fujifilm (Holly Springs, NC)
- …1, CSV is the Subject Matter Expert (SME) and leads tasks associated with Computer System Validation ( CSV ). This role provides input and determine action ... items on all GxP Manufacturing and IT Computerized Systems as well as prepares validation documentation,...and aligns with other FUJIFILM Diosynth Biotechnologies sites for CSV processes and practices + Coordinates with Computer… 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
- Insight Global (San Francisco, CA)
- … software assurance * Proven Experience with software development lifecycle (SDLC) and Computer System Validation ( CSV ) documentation. * Experience with ... risk assessment, change risk assessment) throughout the life cycle of computerized systems . * Execute validation strategies and planning of validation… more
