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3 Key Consulting
Validation Engineer, CSV Biopharma (JP13826)
CSV Validation Engineer at 3 Key Consulting, Ohio. 3-5 yrs pharma/biotech CSV experience. ServiceNow Change Module, CAPA, deviations expertise required. cGMP, 21 CFR Part 11 knowledge. PTO, 401k.
Consulting
Mid-Level
ServiceNow Role Type:
ServiceNow Modules:
Change Management
IT Service Management
ServiceNow Certifications (nice to have):
Job description
Posted on:
March 18, 2025
3Key Consulting is hiring a CSV Validation Engineer for a consulting engagement with a leading global biotechnology company. The ideal candidate has 3-5 years of experience in computerized system validation, deviation management, CAPAs, and change tickets within a GMP-regulated pharmaceutical, biotechnology, or life sciences environment.
Requirements
- 3-5 years of experience in computerized system validation, deviation management, CAPAs, and change tickets within a GMP-regulated pharmaceutical, biotechnology, or life sciences environment
- Bachelor's or master's degree in computer science, Information Technology, Management Information Systems, Mechanical Engineering, or a related field
- Experience with testing tools (ALM, or Kneat or ValGenesis)
- Experience with ServiceNow (Change Module), Track wise (CAPA, Deviations, Change), Veeva document management, CAPA, Deviations, Change Management
- Knowledge of cGMP regulations and guidelines including but not limited to U.S. code of Federal Regulations 21 CFR Part 11 and Part 211
- Understanding of industry standards and best practices for computer system validation such as GAMP 5
Benefits
- Paid time off
- 401k matching
Requirements Summary
3-5 years of experience in computerized system validation, deviation management, CAPAs, and change tickets within a GMP-regulated pharmaceutical, biotechnology, or life sciences environment, Bachelor's or master's degree in computer science, Information Technology, Management Information Systems, Mechanical Engineering, or a related field
