- Lilly (Indianapolis, IN)
- …Eli Lilly and Company. **Position Summary:** The Associate Director of Quality Engineering and Computer System Validation ( CSV ) is responsible for ... Quality Systems related to POINTs Engineering and Computer System Validation processes. The...Validation processes. The Associate Director of Engineering and CSV will work across the POINT organization to provide… more
- VTI Life Sciences (Los Angeles, CA)
- …the biggest companies in the Life Sciences industries. We are looking for an Automation Computer System Validation ( CSV ) Engineer with Emerson Delta-V ... Computer Science, Electrical or Mechanical Engineering preferred + Experience in computer systems validation , Emerson Delta V programming, 21 CFR Part 11,… more
- Mentor Technical Group (Boston, MA)
- …development and execution of Computer System Validation ( CSV ) and Decommissioning deliverables for Laboratory Equipment/ Systems . + Acts as the ... environment is required. + Knowledge of SDLC regulations, including 21CFR part 11, computer systems validation requirements. + Must have experience in… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …**Summary** Manage Global DX Computer System Validation ( CSV ) projects within Daiichi Sankyo, for Computerized Systems supporting GxP and Non-GxP ... regulatory and Daiichi Sankyo requirements, and business expectations. Executes the Global DX Computer System Validation methodology to determine the amount… more
- PACIV (Indianapolis, IN)
- …+ + Execute System Lifecycle deliverables from Commissioning and qualification (C&Q) and Computer System Validation ( CSV ) planning documents through ... PACIV, an international control systems integration and regulatory compliance engineering firm servicing...F&B, and Water/Wastewater clients, is looking for a full-time Validation Engineer (Level I) team member for our USA… more
- Lilly (Indianapolis, IN)
- …automation control system configuration, change control and project delivery, deviation investigation, Computer System Validation ( CSV ) , data mining ... and analysis, and routine automation computer system support activities. The Secondary Loop...system software and hardware. + Configure automation control systems such as Distributed Control Systems (DCS)… more
- Dymax Corporation (Torrington, CT)
- …skills-sets to include ETQ Designer, Python, ETQ Script, SQL, JSP, HTML scripting, and Computer System Validation ( CSV ) principles + Identify quality ... + Experience with ETQ Designer, Python, ETQ Script, SQL, JSP, HTML scripting, and Computer System Validation ( CSV ) principles + 5+ years as a Quality… more
- Insight Global (Athens, GA)
- …Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ . Skills and Requirements 3+ years' experience computer system validation ( CSV ) ... An employer is seeking a Automation Engineer with a proven track record in computer system validation for DeltaV. This will be an ongoing contract for… more
- J&J Family of Companies (Lititz, PA)
- …to have: * Experience working in FDA/cGMP compliance environment preferred. * Knowledge in computer system validation ( CSV ) or in commissioning, ... functional teams. * Assist with Reviews and Executions of Computer System Validation documentation such...* Specialized proficiency in PLC or DCS based control systems , SCADA systems and general automation … more
- Curia (Albuquerque, NM)
- … Engineer will be responsible for supporting Quality Management Systems and Computer System Validation efforts. This role will provide guidance and ... Senior CSV Systems Engineer Albuquerque, NM Curia...functional areas across the organization to maintain and improve computer system validation processes to… more
- Applied Materials (Santa Clara, CA)
- …+ cGMP and manufacturing operations and practices + Good automation Manufacturing Practices (GAMP) and Computer System Validation ( CSV ). + Computer ... of project management and implementation activities for Manufacturing Execution System (MES) projects including requirements definition, configuration, validation… more
- Herbalife (Winston Salem, NC)
- …job aids based on the system functions and the workflow processes. + Support Computer System Validation ( CSV ) activities, as needed. + Deliver ... Labware Laboratory Information Management System (LIMS), Vaisala Continuous Monitoring System (CMS), Valgenesis Validation Lifecycle Management System … more
- Digital Prospectors (Portsmouth, NH)
- …of technical expertise, task management, and leadership. + Present and defend the computer systems validation program and acceptance criteria to ... + Manage and plan the work of the computerized system validation project team. + Assess workload...SDLC regulations including 21CFR part 11, Annex 11, and computer systems validation requirements. +… more
- Quality Consulting Group (Juncos, PR)
- …PowerPoint + Excellent communication and teamwork skills + Process Validation and Computer software validation ( CSV ) knowledge + Capacity to develop ... + Document Nonconformance Reports + Execute and/or approval Manufacturing and Quality System procedure changes + Execute and/or approval of Process Validations and… more
- GRAIL (Menlo Park, CA)
- …management system (eQMS) and learning management system (LMS), including supporting computer system validation ( CSV ) efforts, as needed. + Manage ... role you will be seen as the internal point of contact for Veeva systems changes and implementations to the system per request from internal users/stakeholders.… more
- Amicus Therapeutics (Marlow, OK)
- … Systems team with responsibility for the Quality Management Systems (QMS), Computer System Validation ( CSV ), and Continuous Improvement efforts. ... + Lead QMS-related change management initiatives and projects. + Computer System Quality Assurance: + Oversee the... Quality Assurance: + Oversee the quality of all computer systems used in GxP environments, ensuring… more
- Lilly (Lebanon, IN)
- …of computer systems . **Responsibilities:** + 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
- Lilly (Plainfield, IN)
- …to meet quality and compliance standards. Experience with Good Manufacturing Practices (GMP) and Computer System Validation ( CSV ) regulations, will be ... a related field. + Minimum of 3 years of hands-on experience in providing computer system support within an operational environment. + Understanding of warehouse… more
- J&J Family of Companies (Raritan, NJ)
- …Practices (GxP and GAMP 5). + Working knowledge of Software Lifecycle Qualification, SDLC, Computer System Validation ( CSV ), and Data Integrity standards ... to transform CAR-T Cell Therapy manufacturing and the underlying supply chain systems , into something unique given the limited amount of Cell Therapy manufacturers… more
- VTI Life Sciences (San Diego, CA)
- …Practices) GMP and GDP + Developing and executing IQ, OQ, PQ, and TMV + Experience in computer systems validation . 21 CFR Part 11, Vision Systems and ... Life Sciences industries. We are looking for an Automation CSV Engineer for daily support of our client's Automation...collection of systems spans GMP and non-GMP systems , design, build, commission, validation and possible… more