Job Description

Computer System Validation (CSV) Lead
Job Number: 21-13684
Use your skills where innovative technology solutions begin. Eclaro is looking for a Computer System Validation (CSV) Lead for our client in Cambridge, MA.
Eclaro’s client is a leading technology solutions provider, collaborating with customers to manage their needs and achieve success in their business goals. If you’re up to the challenge, then take a chance at this rewarding opportunity!
Position Overview:
  • Computer System Validation (CSV) lead with experience in Laboratory Information management Systems (Labvantage/ Labware), Clinical applications, Veeva Vault Platform and Quality Management Systems.
  • The resource should be able to manage the team and drive the project.
  • Create a validation plan using a risk-based approach.
  • Create a validation report that verifies compliance to the plan.
  • Review requirements specification for compliance with the applicable regulatory requirements and that they are unambiguous and testable.
  • Review executed operational, performance qualification documents for verifying that the testing effort has been completed, defects captured, objective evidence attached.
  • Write, review, evaluate the configuration management plans and procedures associated with the development process.
  • Verify that requirements can be traced through design, code, and test phases as applicable, creating Traceability Matrix.
  • Raising a CR with proper description, reason for change, implementation plan, impact assessment and other requirements per customer's SOP; Reviewing and verify execution of CR; Monitoring CR through closure
  • Raising a deviation, processing, investigation, causal analysis, implementation, efficacy, closure, and other requirements per customer's SOP.
  • Raising an IT CAPA, initiation, action processing, root cause analysis.
  • Monitoring deviations and CAPAs for extension, amendment, approval, and closure.
  • Conduct post-implementation; periodic review of systems.
  • Dry run and execute test protocols. Review executed test scripts.
Required Skills:
  • 8+ years of relevant experience
  • Hand on experience of supporting Computer System Validation
  • Experience with industry-standard and best practices regarding quality, quality assurance and quality control principles and techniques (e.g., 21 CFR Part 11, GAMP 5)
  • Knowledge of GxP best practices, international standards to quality management and methodology.
  • Proven experience collaborating with others, including employees and contractors
  • Effective communication skills (written and oral)
  • Effective and independent problem-solving skills
  • Great team player
If interested, you may contact:
Steve Adams
Steve Adams | LinkedIn
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Application Instructions

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