- Mentor Technical Group (NC)
- …+ Responsible for the development and execution of Computer System Validation ( CSV ) and Decommissioning deliverables for Laboratory Equipment/Systems. + Acts as the ... on-site project leader to plan, execute, and complete control systems projects with assigned client sponsor. + Performs or delegates tasks as required to execute and fully complete assigned projects. + Coordinates communication with the client sponsor during… more
- Mentor Technical Group (PR)
- …Qualifications Requirements/Knowledge/Education/Skills: + BBA in Engineering + Knowledge in CSV + Problem Solving Knowledge (Yellow or Green Belt knowledge) ... Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibiran consideracion para el empleo sin importar raza, color, religion, sexo, orientacion sexual, identidad de genero, informacion genetica,… more
- VTI Life Sciences (San Diego, CA)
- …the Life Sciences industry. We are looking for a Computer System Validation ( CSV ) Specialist to be responsible for ensuring that computerized systems used in ... regulated environments are validated in compliance with industry standards, regulatory requirements (such as FDA 21 CFR Part 11 and 820, Data Integrity, ISO 13485 and GAMP 5.), and company policies. The role includes the development and execution of validation… more
- Mentor Technical Group (Caguas, PR)
- …+ Collaborate with C&Q Engineers to develop and maintain commissioning and qualification procedures and documents. + Write, review, and approve C&Q protocols and ... Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance… more
- Jabil (Hunt Valley, MD)
- …Develops and implements quality plans, programs, and procedures using quality control statistics, lean manufacturing concepts, and analyses. Ensures that performance ... and product quality conforms to established company, customer and requirements. Reviews, analyzes and reports on quality discrepancies related to assembly and process. Investigates problems and develops dispositions, modifications and corrective actions for… more
- Catalent Pharma Solutions (Harmans, MD)
- …**City:** Harmans **State** : MD **JOB DESCRIPTION** : + Serve as the QA- CSV liaison with the Engineering, Quality Control, IT and Validation organizations to ... QA oversight for the site on global implementation of CSV policy and review System Impact Assessment (SIA), Data...QC and IT to provide training and coaching on CSV projects and data integrity initiatives; Provide input into… more
- Insight Global (Basking Ridge, NJ)
- …to enhance and verify the compliance and computer systems validation ( CSV ) capabilities across systems managed by Global Development Information Management (G-DIM). ... CAPA plans, training and awareness sessions on inspection readiness and acting as CSV advisor on new implementations, changes and incidents. Lead and execute CSV… more
- Abeona (Cleveland, OH)
- …Validation Reports to: Director of Validation As a Computer System Validation ( CSV ) Engineer in a biotechnology environment, you will play a critical role ... Functional and Design Specifications, Test Plans, and Summary Reports. . Lead CSV efforts for systems supporting biotech processes such as: . Laboratory systems… more
- Catalent Pharma Solutions (Harmans, MD)
- …Catalent Pharma Solutions in Harmans, MD is hiring a Senior Engineer, CSV who is responsible for participating in validation projects related to manufacturing ... with a minimum of five (5) years of direct CSV engineering experience; + Able to work in a...as well as routine quality tasks; + Experience with CSV Commissioning and Qualification activities in a regulated industry;… more
- Lilly (Indianapolis, IN)
- …hypercare support and frontline troubleshooting. + Ensure compliance with Computer System Validation ( CSV ) standards, including 21 CFR Part 11 and GAMP 5. + Develop ... + Working knowledge of cGMP and Computer System Validation ( CSV ) frameworks + Ability to interpret process requirements and...+ Understanding of GMP regulations and Computer System Validation ( CSV ) principles (eg, GAMP 5, 21 CFR Part 11,… more