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Computer programming • carlsbad ca
Última actualización: hace 5 horas
Computer System Validation Specialist.Location : Oceanside, California.Validation Protocol Development & Execution.Commissioning and Qualification Protocols.
CQ, IQ, OQ, PQ), including comprehensive ...Mostrar másÚltima actualización: hace 5 horas
Join our mission to help transform healthcare delivery from reactive, episodic care to proactively managed patient care that prevents live-changing problems before they happen for patients with two...Mostrar másÚltima actualización: hace más de 30 días
Santa Rosa Junior College is currently accepting applications to establish a pool for part-time associate faculty assignments.
Associate assignments are temporary, part-time or on-call.This job post...Mostrar másÚltima actualización: hace más de 30 días
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Computer System Validation Specialist
Staftonic LLCOceanside, CA, United StatesA tiempo completo
NON-COMPACT STATE - PT Remote CCM / RTM Care Management Nurse (CA)
Harris ComputerRemote, CATeletrabajo
A tiempo completo +1
COMPUTER SCIENCE
Santa Rosa Junior CollegeSonoma County, CAA tiempo completo +1
Computer System Validation Specialist
Staftonic LLCOceanside, CA, United StatesHace 5 horas
Tipo de contrato
- A tiempo completo
Descripción del trabajoEducation : Bachelor’s degree in Engineering, Life Sciences, Computer Science, or related discipline (advanced degree preferred). Experience : Minimum 7+ years of Computer System Validation (CSV) experience in FDA-regulated environments (pharmaceutical, biotechnology, or medical devices). Regulatory Expertise : Strong, working knowledge of 21 CFR Part 11, 21 CFR Part 820, ISO 13485, GAMP 5, and Data Integrity principles . Technical Skills : Hands-on experience in authoring and executing validation protocols, test scripts, and system lifecycle documentation . At least 5+ years of SQL experience for data mining, system testing, and report validation. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, MS Project, Visio) for technical writing and reporting. Soft Skills : Exceptional technical writing, documentation review, and analytical abilities . Strong organizational and communication skills with the ability to collaborate across departments. Demonstrated ability to work independently in a fast-paced, regulated environment .
Computer System Validation Specialist
Location : Oceanside, California
Long Term Project
Key Responsibilities
- Validation Protocol Development & Execution
- Develop, author, and execute Software Test Protocols to verify system functionality and compliance.
- Draft, route, and execute Commissioning and Qualification Protocols (CQ, IQ, OQ, PQ), including comprehensive final reports.
- Perform end-to-end validation lifecycle activities, from planning through approval and closeout.
- System Qualification & Data Analysis
- Plan, schedule, and execute qualification activities to support system readiness.
- Collect, analyze, and interpret qualification data against acceptance criteria.
- Identify and document deviations, discrepancies, and resolutions to ensure compliance.
- Documentation & Compliance Oversight
- Draft, review, and maintain key documents, including User Requirement Specifications (URS), Software Requirement Specifications (SRS), Software Design Specifications (SDS), SOPs, PFMEA, and validation forms .
- Ensure compliance with cGMP, GDP, and FDA cGxP regulatory standards , incorporating risk-based approaches.
- Support the creation and update of procedures and best practices related to system validation and data integrity.
- Project & Audit Support
- Actively participate in project meetings, providing status updates and ensuring alignment with timelines.
- Coordinate with cross-functional stakeholders to support system implementation and compliance readiness.
- Prepare and present validation documentation for internal and external audits / inspections , ensuring audit readiness at all times.
Qualifications & Requirements