CSV Engineer
6 days ago
Katalyst Healthcares and Life Sciences is seeking a highly skilled Validation Specialist to join our team. As a CSV Engineer, you will play a critical role in ensuring the quality and compliance of our systems and processes.
Key Responsibilities- Project Management: Collaborate with project managers and client personnel to understand project objectives and develop comprehensive project plans.
- Validation Planning: Author validation plans, user requirements documents, and system requirements documents to ensure compliance with regulatory requirements.
- Testing and Quality Assurance: Develop and execute testing plans and scripts, prepare test summary reports, and finalize validation reports to ensure system quality and compliance.
- Electronic Record Management: Manage and maintain electronic records in client document management systems to demonstrate compliance with government regulations.
- System Integration: Support maintenance and enhancements for client custom integrations between Veeva QualityDocs and Cornerstone.
- Consultation and Collaboration: Consult with client personnel to ensure validation activities and deliverables meet client corporate policies and procedures.
- Education: Degree from an accredited, four-year college or university; advanced degrees and certificates/certifications are highly desirable.
- Experience: At least 5 years of relevant work experience in a computer system validation (CSV) role in the biotech/pharmaceuticals industry; knowledge of applicable regulations and guidance is highly desirable.
- Technical Skills: At least 3 years of relevant work experience with Cornerstone On Demand; bonus points for experience in Compliance Wire, Veeva Quality Docs, SQL, and Python.
- Project Management and Validation Methodology: Grounded in solid project management and system validation methodology, with the ability to set and manage expectations extremely well.
- Quality Results: Proven track record of delivering quality results while handling multiple projects and competing priorities.
- Risk Management: Thorough understanding of a Risk Management-Based Approach to system validations, including system risk categories and system class (GAMP 5).
- Regulatory Knowledge: Working knowledge of 21 CFR Part 11 and Annex 11, as well as understanding of regulations around personal and patient data privacy (GDPR).
- Leadership and Experience: Experience leading a validation project, authoring validation plans, and using Electronic Document and Quality Management Systems such as Veeva, Qualio, or Master Control.
- Test Coordination and Management: Experience with test coordination and testing management, including training users on executing test protocols and managing test results through the process.
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Validation Specialist
6 days ago
Chula Vista, California, United States Katalyst Healthcares and Life Sciences Full timeAbout the RoleKatalyst Healthcares and Life Sciences is seeking a highly skilled Validation Specialist to join our team. As a CSV Engineer, you will play a critical role in ensuring the quality and compliance of our clients' systems and processes.Key ResponsibilitiesProject Management: Collaborate with project managers and client personnel to understand...
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System Validation Expert
7 days ago
Chula Vista, California, United States Katalyst Healthcares and Life Sciences Full timeAbout the RoleKatalyst Healthcares and Life Sciences is seeking a highly skilled Validation Specialist to join our team. As a CSV Engineer, you will play a critical role in ensuring the quality and compliance of our clients' systems and processes.Key ResponsibilitiesProject Management: Collaborate with project managers and client personnel to understand...
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CSV Engineer
2 months ago
Chula Vista, United States Katalyst Healthcares and Life Sciences Full timeResponsibilities: Work with project manager and client personnel to understand overall project objectives. uthor validation plans, user requirements documents and/or system requirements documents, configuration/design specifications, risk assessments, test protocols, traceability matrices, data migration plans, and change records. uthor and review...
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Manager, Integrations Engineering
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La Vista, United States The Ladders Full timeAbout Us: CyncHealth is a statewide Health Information Exchange (HIE) with a purpose to achieve health care transformation through community betterment and collaboration while protecting the security and privacy of medical information. Join our team to play a key role in leading a health data utility, advancing interoperability, and improving healthcare....