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Computer Systems Validation Engineer

Cagents
Location
Boston, Massachusetts
Posted
25 days ago
Department
Northeast
What they actually want (must-haves)
  • Bachelor's degree in Computer Science, Engineering, or related field
  • Minimum of 3+ years of experience in computer systems validation
  • In-depth understanding of GAMP guidelines and FDA regulations (21 CFR 11, 210, 211)
  • Familiarity with S88/S95 batch control standards
  • Excellent oral and written communication skills in English
  • Ability to travel domestically and internationally as required
Nice to have
  • Experience in biotech or pharmaceutical environments
  • Experience with Rockwell platforms, DeltaV systems, and recipe authoring in batch environments
  • Experience with multiple automation and manufacturing execution systems
  • Data integrity assessment/remediation experience
What the job really is

The Computer Systems Validation Engineer at CAI will be responsible for authoring GxP computer validation documentation, generating and executing test protocols, and ensuring compliance with FDA regulations. The role involves supporting CSV activities across various platforms, engaging with major systems, and collaborating with client teams to ensure validation compliance and delivery.

Things to weigh
  • No salary listed
  • Experience in biotech or pharmaceutical environments preferred over medical device
  • Willingness to work paid overtime when needed
Job score2.6/5
Benefits1/5
Freshness4/5
Career value4/5
Role clarity4/5
Pay transparency0/5

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