- 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
- J&J Family of Companies (Wilson, NC)
- …purchase, eLims support, laboratory equipment lifecycle management and CSV support coordination, among others. **Key Responsibilities:** + Responsible ... lifecycle management including Analytical Instrument Qualification (AIQ) and Computer System Validation ( CSV ), among others. + Perform budget support as the point of… more
- Merck (Durham, NC)
- **Job Description** The Digital Foundational Services, US Capital Project CSV , Senior Specialist role is charged with the administration of regulatory compliance ... activities across sites. + Ensure compliance with Computer Systems Validation ( CSV ) and Systems Development Lifecycle (SDLC), Cyber Security and Data Integrity… more
- J&J Family of Companies (Wilson, NC)
- …key role, you will be responsible for laboratory equipment lifecycle management and CSV support, among others. J&J is expanding our manufacturing capacity with $2 ... + Responsible for the quality control laboratory equipment lifecycle management and CSV support. + Participate in the qualification of analytical equipment for… more
- Cognizant (Raleigh, NC)
- …Strong understanding of GMPs, regulatory compliance, and computer system validation ( CSV ) principles. . Excellent communication skills, with the ability to influence ... stakeholders at all levels. . Experience in mentoring and developing junior engineers and technical leads. . Ability to manage multiple priorities and stakeholders in a dynamic project environment. **SKILLS** . Strategic thinker with a proactive and… more
- Lumen (Raleigh, NC)
- …from various sources and formats, such as relational databases, APIs, JSON, XML, CSV , etc. + Perform data quality checks and validations, and handle data anomalies ... and issues + Collaborate with other developers, data engineers, data analysts, and business stakeholders to understand data requirements and deliver data solutions + Develop scalable systems that enable real-time validation of identified resources + Mentor… more
- Lucid Software (Raleigh, NC)
- …down ideas **Preferred Qualifications:** + Experience working with large datasets (databases or CSV files) + Experience in one or more of the following areas is ... a plus: innovation, organizational agility, software architecture, digital transformation, cloud migration, product development, digital transformation, change management, Hybrid work, etc + Experience enabling and integrating with third-party SSO identity… more
- Cognizant (Raleigh, NC)
- …in C# and object-oriented programming concepts Author Computer System Validation ( CSV ) documents such as Functional Risk Assessment, Validation Plan, System Test ... Plan, Test Summary Reports (IQ/OQ/UAT), Validation Report, etc. following industry standard GAMS 5 and/or following the client Quality standards. Author and review test scripts (IQ, OQ, PQ) Perform IQ (application and devices), OQ (including the Siemens… more
- Cambrex High Point (High Point, NC)
- …Qualifications/Skills + Knowledge and Experience in Computer System Validation ( CSV ). + Knowledge of Electronic Quality Management/Document Systems preferred. + ... Excellent verbal and written communication and interpersonal skills, problem-solving, and organizational skills. + Track record of successfully applying high level scientific judgment in a variety of complex and unprecedented situations. + Proven ability to… more
- Lilly (Concord, NC)
- …preferred. **Additional Preferences** + Understanding of GMP regulations and Computer System Validation ( CSV ) principles (eg, GAMP 5, 21 CFR Part 11, Annex 11). + ... Experience authoring and validating Master Batch Records (MBRs) in a regulated environment. + Strong documentation skills and attention to detail, with experience in generating validation deliverables and training materials. + Ability to work… more