CSV and Validation Engineer

Remote • Posted 60+ days ago • Updated 10 hours ago
Full Time
On-site
Fitment

Dice Job Match Score™

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Job Details

Skills

  • Informatics
  • Documentation
  • Test Plans
  • Data-flow Diagrams
  • Backup
  • Recovery
  • Auditing
  • Traceability Matrix
  • Management
  • Corrective And Preventive Action
  • Change Control
  • Training
  • Collaboration
  • Quality Assurance
  • Computerized System Validation
  • Life Sciences
  • Data Integrity
  • GAMP
  • URS
  • FRS
  • DirectShow
  • DS
  • RTM
  • IQ
  • OQ
  • PQ
  • LIMS
  • ELN
  • Middleware
  • Application Lifecycle Management
  • JIRA
  • Veeva
  • Master Control
  • Trackwise
  • Technical Writing
  • Communication

Summary

Job Description:
We are seeking a hands-on CSV and Validation Engineer to validate software used with laboratory instruments and lab informatics platforms. The role owns risk-based validation planning and execution aligned to EMA Annex 11 and 21 CFR Part 11, authors audit-ready documentation, and partners with QA/IT/Lab to transition systems to standardized SOPs.
Responsibilities:
  • Plan and execute computer system validation using a risk-based CSA approach aligned to GAMP 5.
  • Validate instrument software and lab systems; author URS, FRS, DS, test plans, IQ/OQ/PQ, traceability, and validation summary reports.
  • Design and maintain infrastructure and data flow diagrams covering integrations, security, backup/restore, and audit trails.
  • Capture business and technical requirements; maintain a bidirectional requirements traceability matrix.
  • Execute test cycles, log defects, drive remediation, manage deviations/CAPA, and support inspections.
  • Ensure change control, periodic review, training effectiveness, and release readiness for validated systems.
  • Collaborate across QA/CSV, IT, and Lab teams; provide clear communication and stakeholder updates.
Requirements:
  • 5 to 10+ years in CSV/validation within regulated labs or life sciences.
  • Strong knowledge of EMA Annex 11, 21 CFR Part 11, data integrity (ALCOA+), and GAMP 5.
  • Proven authorship of URS/FRS/DS, RTM, IQ/OQ/PQ, and validation summary reports.
  • Experience with LIMS, ELN, CDS, or instrument control software; familiarity with instrument integrations and middleware.
  • Proficiency with test and quality tools such as Client ALM/Jira/Xray, ValGenesis, Veeva, MasterControl, or TrackWise.
  • Excellent technical writing, organization, and cross- functional communication.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91116760
  • Position Id: 3281bcec3de5c886a4edeec2e9b13c95
  • Posted 30+ days ago
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