Computer System Validation Consultant -analytical Instruments

Agilent CrossLab Group

Base: $93,760.00 - $146,500.00pyr; bonus/equity: e...
Fully remote
Computerized system validation (csv)
Gamp® 5 methodology
Data integrity assessment/remediation
Agilent CrossLab Group is seeking a Computer System Validation Consultant with experience in regulatory compliance for FDA-regulated markets. The role primarily involves delivering compliance consulting services related to computerized system validation and data integrity within laboratory environments, with a strong focus on quality assurance and project management

Job Summary

  • Deliver compliance consulting services to customers in FDA regulated markets focused on Computerized System Validation (CSV) and Data Integrity.
  • Responsibilities include authoring and executing CSV documents, managing compliance projects and vendors, and ensuring customer satisfaction.
  • This role requires a BS/BA in a relevant field with 4+ years of experience in Computer System Validation and the pharmaceutical/healthcare industries.

Matching Summary

Match Score: 85

Agilent CrossLab Group is seeking a Computer System Validation Consultant with experience in regulatory compliance for FDA-regulated markets. The role primarily involves delivering compliance consulting services related to computerized system validation and data integrity within laboratory environments, with a strong focus on quality assurance and project management.

Salary

Base: $93,760.00 - $146,500.00/yr; Bonus/Equity: eligibility for bonus, stock; Benefits: eligibility for benefits

Skills & Requirements

Must-have

  • Computerized System Validation (CSV)
  • GAMP® 5 methodology
  • Data Integrity assessment/remediation
  • US FDA 21 CFR Part 210/211
  • US FDA 21 CFR Part 11
  • Eudralex Annex 11

Nice-to-have

  • Scientifically sound laboratory practices
  • Quality assurance experience
  • SOP writing services
  • Microsoft Project, Visio

Key Requirements

  • 4+ years' experience in Computer System Validation
  • 4+ years' experience in Pharmaceutical or Healthcare Industries
  • B.S./B.A. in Engineering, Science, Information Technology, or related field
  • Experience in validation of at least two computer system categories

Work Rights

Not specified

Tailored Resume

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