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← Care Access

Computer Systems Validation Engineer

Care Access
Location
USA Remote
Posted
16 days ago
Department
Global Delivery
Salary
$80,000 - $120,000
What they actually want (must-haves)
  • Strong knowledge of GAMP 5 guidelines
  • Knowledge of FDA 21 CFR Part 11
  • Experience with ICH E6(R3) Good Clinical Practice
  • Understanding of EU CTR 536/2014
  • 4+ years of direct CSV experience in a regulated life sciences or clinical research field
  • Hands-on experience with validation of life sciences/clinical applications
Nice to have
  • Degree in Computer Science, Engineering, Life Sciences, or related field
What the job really is

The Computer Systems Validation Engineer at Care Access is responsible for validating and maintaining computerized systems to ensure compliance with regulatory requirements and internal policies. This role involves collaboration with various departments to ensure systems are fit for use, managing validation documentation, conducting risk assessments, and participating in audits. The position is fully remote and requires minimal travel.

Benefits
  • Paid Time Off (PTO) and Company Paid Holidays
  • 100% Employer paid medical, dental, and vision insurance plan options
  • Health Savings Account and Flexible Spending Accounts
  • Bi-weekly HSA employer contribution
  • Company paid Short-Term Disability and Long-Term Disability
  • 401(k) Retirement Plan, with Company Match
Things to weigh
  • Role requires 100% remote work
  • Less than 5% travel requirements
  • No salary listed beyond the range of $80,000 - $120,000
  • Care Access is unable to sponsor work visas
Job score4/5
Benefits3/5
Freshness4/5
Career value4/5
Role clarity4/5
Pay transparency5/5

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