- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune disorders.Summary Manage Global DX Computer System Validation ( CSV ) projects within Daiichi Sankyo, for Computerized Systems supporting GxP and ... computer system validation or qualification of global GxP and Non-GxP computer systems .Create and review various validation documentation such as … more
- Fujifilm (College Station, TX)
- …applicable points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation ( CSV ) and Lifecycle ... and files. + Supports regulatory and client audits as CSV subject matter expert. + Perform other duties as...engineering principles. + Working knowledge and expertise in computerized systems validation . + Computer System… more
- Fujifilm (College Station, TX)
- …applicable points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation ( CSV ) and Lifecycle ... a source of pride for the area. The Manager, CSV will be responsible for management, scheduling, and oversight...engineering principles. + Working knowledge and expertise in computerized systems validation . + Computer System… more
- Eastman (Kingsport, TN)
- …Computerized Systems across their lifecycle, ensuring adherence to regulatory standards, Computer Systems Validation ( CSV ), and Data Integrity ... . Responsibilities + Develop 21 CFR Part 11 compliant computer systems validation plans, IQ/OQ... documents + Ensure initiation/preparation and closeout of all CSV related deviations, discrepancies and change control documents. +… more
- IQVIA (Cary, NC)
- …the proper implementation of Software Development Lifecycle (SDLC) methods as they relate to Computer Systems Validation ( CSV ), IT Quality Systems ... to be validated to be compliant with 21CFR Part 11. + Expert knowledge of Computer Systems Validation ( CSV ) in a life science or regulated environment… more
- Bristol Myers Squibb (Princeton, NJ)
- …and scrum methodologies preferred. + Knowledge of Software Development Lifecycle (SDLC) and of computer systems validation ( CSV ) + Knowledge of cGXP ... of a team. Additionally, you will support the execution of Computer Systems Validation processes. **Desired Candidate Characteristics:** + Prior experience… more
- Astellas Pharma (Sanford, NC)
- …and SDMS lab systems + Knowledge of manufacturing processes, equipment qualification and computer systems validation ( CSV ) according to GAMP 5 ... the system administration, maintenance and enhancements to facilitate changes to laboratory systems and business processes in a complex Scientific IT landscape to… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …tools and framework + Must have knowledge of Software Development Lifecycle (SDLC) and of computer systems validation ( CSV ) + Strong Project Management ... business goals and ensure the seamless integration of applications and data systems . This role involves coordinating project-related efforts across a wide range of… more
- Belcan (Indianapolis, IN)
- Computer System Validation ( CSV ) Program Lead Job Number: 352755 Category: -MFG & Supply Chain SBU Description: Job Title: CSV ( Computer System ... Shift: 1st #CSVLeadership #PharmaValidation #ComplianceExcellence Overview: We are seeking an experienced CSV ( Computer System Validation ) Program Lead to… more
- PACIV (Indianapolis, IN)
- …and compliance standards. If you're ready to step into a leadership role in computer systems validation and drive impactful change, the Principal ... About PACIV: We are a global leader in control systems integration and regulatory compliance engineering. For over two...CSV Program Lead to set up and oversee CSV ( Computer System Validation ) deliverables… more
- ThermoFisher Scientific (Durham, NC)
- …the biotech or pharmaceutical industry with familiarity in Good Manufacturing Practices (GMP) and Computer Systems Validation ( CSV ). + Knowledge of SQL, ... seeking a highly skilled and experienced Sr. Manager to oversee the IT systems and services within our Production Chemicals and Services Business. The Sr. Manager… more
- CREO (Durham, NC)
- …SC-300, AZ-500, SC-200). + Experience in Governance Risk and Compliance (GRC). + Experience with computer systems validation ( CSV ) and 21 CFR Part11 ... assessment, acceptance and mitigation of risks to the organization's information systems and data. + Implement and/or assess enterprise IT security controls,… more
- Curia (Albuquerque, NM)
- …responsible for supporting Quality Management Systems and Computer System Validation efforts. Additionally, the CSV Systems Engineer III will provide ... CSV Systems Engineer III in Albuquerque, NM...experience working in a cGMP regulated industry specific to computer systems validation + Validation… more
- Fujifilm (Holly Springs, NC)
- …2, CSV is the Subject Matter Expert (SME) and leads tasks associated with Computer System Validation ( CSV ). This role provides input and determine action ... validation status of Manufacturing and IT Computerized Systems + Manages the allocation of contract CSV...and aligns with other FUJIFILM Diosynth Biotechnologies sites for CSV processes and practices + Coordinates with Computer… more
- Lilly (Lebanon, IN)
- …to enable a successful startup into GMP manufacturing operations. **Position Overview** As a Computer System Validation Engineer, you will play a pivotal role in ... will provide CSV support leading and executing CSV activities for process automation systems across...FRS, FS, DS, etc) documentation. + Develop and execute Validation Plan, Validation Strategies, Trace Matrix, Test… more
- Verista (New Brunswick, NJ)
- …+ Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/ systems / software, and processes ... + Conduct risk assessments and implement mitigation strategies for computerized systems . + Oversee documentation lifecycle for CSV activities, ensuring… more
- Verista (Boston, MA)
- …Qualifications Protocols, Trace Matrices and Summary Reports associated with validated computer systems + Engage in Quality process improvement initiatives, ... our collective expertise Senior CSV Engineer/Analyst Responsibilities: + Provide IT CSV support to implement and validate electronic systems in accordance… more
- Quality Consulting Group (Manati, PR)
- …area. + Manage the validation of in-house projects for computer and automated systems for Laboratory, Sterile, Non-Sterile and Utilities/Facilities ... systems . + EBRs, Laboratory Analytical instruments upgrade initiative, and CSV IT Compliance activities including development of validation documents,… more
- Mentor Technical Group (Carolina, PR)
- … Summary Report). + Working knowledge of the development of protocols for the Validation of complex computer systems (eg, multiple GAMP classes of ... in Project execution within at least one area of systems validation - eg, laboratory equipment, facilities...5 plus years of experience in the field of computer validation . Mentor Technical Group es un… more
- Carrier (Beverly, MA)
- …day. Join us and we can make a difference together. **About this role** As a Computer Systems Validation Lead, you will lead and manage the Validation ... Program for Sensitech systems and products. The Validation Lead will work with the Sales, Product, Engineering,...expectations. **Key Responsibilities:** + Define and maintain a global Computer System Validation ( CSV ) methodology… more
