Data Systems Validator

3 days ago

Dublin, Dublin City, Ireland beBeeValidation Full time €60,000 - €100,000

Validate computer systems for life sciences companies.

Key Responsibilities:
  • Develop and execute protocols and test scripts to identify gaps, consult on, and direct plans for resolution.
  • Write GxP computer validation and 21 CFR Part 11 related documentation such as assessments, plans, URS, FRS, RTM, and summary reports.
Requirements:
  • Bachelor's degree in Computer Science or Engineering field or equivalent experience.
  • 1-3 years of experience with Computer systems validation.
  • 1 year of experience working in a GMP environment.
  • Data Integrity experience with GAMP and 483 compliance consent decree experience deep 21CFR Part 11 experience is a plus.
  • Experience in biotech and pharma is preferred over medical device.
  • Experience with MES Delta V PI is a plus.
We Utilize:
  • Rockwell
  • GE
  • Emerson
  • ABB
  • Werum
  • Siemens
  • Honeywell
  • PAS-X
  • Syncade
  • FactoryTalk
  • PharmaSuite
  • Control Logix
  • PLM
  • Simatic
  • iFix
  • Wonderware

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