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Validation Specialist for Computer Systems

2 months ago

Somerset, New Jersey, United States LabVantage Full time
Job Summary

LabVantage is seeking a highly skilled Computer Systems Validation Specialist to join our team. As a key member of our team, you will be responsible for delivering Computer Systems Validation (CSV) services to our clients.

Key Responsibilities
  • Validation Consulting Services: Provide advisory services to LabVantage clients on CSV, creation of validation documentation and solutions aligned with relevant regulation standards.
  • Project Management: Manage customer expectations, deliver high-quality validation documentation, and execute test scripts when required.
  • Regulatory Compliance: Work with LabVantage employees and external regulatory bodies on the overall compliance strategy, including interaction with Quality Engineering, Product Development, Product Marketing, and Product Management.
  • Training and Mentoring: Provide training and mentoring in computer systems validation to all relevant personnel.
  • Continuous Improvement: Identify and enforce necessary system corrections and improvements to established systems and processes via system change controls and mitigation plans.
Requirements
  • Proven Experience: Proven experience as a CSV specialist in a consulting organization.
  • Industry Knowledge: In-depth knowledge of validation deliverables associated with each step of the computer system lifecycle, industry standards, and applicable regulatory guidance and rules.
  • Technical Skills: Experience with generating and reviewing validation deliverables, change control processes, CAPA, and Quality Systems.
  • Soft Skills: Strong organization and time management skills, critical and analytical thinking, creative problem-solving skills, and superior written and verbal communications and presentation skills.
Preferred Qualifications
  • Project Management Skills: Ability to work in cross-functional teams and build consensus across diverse groups.
  • Technical Writing Skills: Technical writing skills in English.