- Merck & Co. (Rahway, NJ)
- …Assurance community, provide for and lead Quality Assurance oversight for computer system validation matters within the Global Development Quality organization ... build Quality Management System elements into the end-to-end computer system validation process, thereby promoting permanent inspection readiness.Develop and… 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 ... computer system validation . As a Computerized Systems Validation Engineer, you...Validation Engineer will be responsible for ensuring all Computerized Systems Validation ( CSV… more
- Bristol Myers Squibb (Devens, MA)
- …Facility (CTF). The Senior CSV Engineer will be responsible for managing the computerized system validation ( CSV ) activities for major projects to ... highly skilled and motivated Senior Engineer - IT Computer System Validation ( CSV ) to join...on quality assurance, validation , or compliance for computerized systems . + Knowledge of CSV… more
- PACIV (San Juan, PR)
- …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...and execution of CSV deliverables throughout the System Development Life Cycle of industrial systems .… more
- Harmac Medical Products (Buffalo, NY)
- …$80,000-$85,000 Description Job Summary The Software Quality Engineer ensures the compliance of computerized systems validation ( CSV ) according to ... support to all Harmac Medical Product Facilities in the Computerized System Validation Process. This...+ Minimum of 3 years of experience working with computerized systems validation . + Minimum… more
- Fujifilm (Holly Springs, NC)
- …operations launch * Ensures the integration of process validation (PV), CV, and computerized system validation ( CSV ) into the overall CQV strategy. ... validation sections of CTDs and NDAs * Experience of Electronic Validation systems such as KNEAT or similar * Experience of Lives Temperature Mapping … more
- Charles River Laboratories (Memphis, TN)
- …passionate about. **Job Summary** Manage staff specific to computerized system validation projects. Provide support for CSV staff, System Owners and ... Quality Assurance and IT staff to promote the understanding of * computerized system validation , regulatory requirements, and corporate policies.… 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 ... Validation Specialist is primarily responsible for leading, implementing and managing Computer System Validation ( CSV ) and Data Integrity Programs (DI),… more
- Amgen (Washington, DC)
- …all architecture and system configuration decisions align with 21 CFR Part 11 computerized systems validation ( CSV ) and GxP regulatory frameworks. + ... Analyze current business processes, legacy systems , and requirements to create comprehensive EAM designs. +...center. + Serve as technical authority across build, test, validation , and deployment phases. + Work with consultants and… more
- Curia (Albany, NY)
- … CSV Systems Engineer will be responsible for supporting Quality Management Systems and Computer System Validation efforts. This role will provide ... platform + And more! Responsibilities Computer Systems Validation + Manage multiple site and global CSV...team members to keep apprised of computerized system needs, impacts on computer validation , project… more
- Fujifilm (Holly Springs, NC)
- …CSV is the Subject Matter Expert (SME) and leads tasks associated with Computer System Validation ( CSV ). This role provides input and determine action ... on all GxP Manufacturing and IT Computerized Systems as well as prepares validation documentation,...CSV processes and practices + Coordinates with Computer System vendors, as needed + Assesses the impact of… more
- Lilly (Lebanon, IN)
- … Validation Plan. * Provide subject matter expertise for computer system validation and data integrity for automation systems across the site including: + ... System + QMS * Perform risk assessments for computerized systems and develop strategies to mitigate...strategies to mitigate identified risks * Develop and Execute validation protocols for computerized systems … more
- Insight Global (San Francisco, CA)
- …functional risk assessment, change risk assessment) throughout the life cycle of computerized systems . * Execute validation strategies and planning ... of validation activities; Oversee execution of validation activities for non-product computerized systems...Proven Experience with software development lifecycle (SDLC) and Computer System Validation ( CSV ) documentation. *… more
- Charles River Laboratories (Memphis, TN)
- …you can feel passionate about. **Job Summary** BASIC SUMMARY: Responsible for computerized system validation activities within CRL Manufacturing Operations, ... and maintaining quality throughout. * Prepare clear and concise validation deliverables for computerized systems ,... system and regulatory requirements in conjunction with computerized system validation . Oversee test… more
- Fujifilm (College Station, TX)
- …knowledge of engineering principles. + Working knowledge and expertise in computerized systems validation . + Computer System Validation experience ... Systems at all applicable points of the computerized system lifecycle, ensuring compliance with regulatory...system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation ( CSV ) and Lifecycle… more
- J&J Family of Companies (Wilson, NC)
- …computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation ( CSV ) and Lifecycle procedures with Data ... site. This role will be part of our computer system validation team for Wilson, NC site....Automation Lead and is responsible for supporting all GxP-Regulated Computerized Systems at all applicable points of… more
- Bristol Myers Squibb (Summit, NJ)
- …the Qualification of equipment and full CSV for single and multi-user Computerized Systems . + Develops validation /qualification deliverables such as ... BMS with our Cell Therapy team. The **Lead Computer System Validation ( CSV ) Engineer** supports...the successful implementation of manufacturing and laboratory equipment and computerized systems at multi-use sites through interaction… more
- VTI Life Sciences (San Diego, CA)
- …Scripts. + 3+ years of proven experience with SQL, Software Validation and Computerized Systems Validation . + Must have experience working in an ... Life Sciences industry. We are looking for a Computer System Validation ( CSV ) Specialist to...CSV ) Specialist to be responsible for ensuring that computerized systems used in regulated environments are… 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 ... systems validation requirements. + Must have experience in configuring computerized systems with complex vendor software systems , and windows… more
- Lilly (Lebanon, IN)
- …business partners **Basic Requirements:** * Minimum BS in Engineering and experience in Computerized System Validation and Data Analytics, preferably in ... Provide subject matter expertise for computer system validation and data integrity for automation systems ...Electronic testing system (Kneat, ALM, Valgenesis) managing CSV document relating to automation systems **Operational… more
