Computer System Validation Lead / Program Manager

Added
25 days ago
Type
Full time
Salary
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Related skills

sap csv ctms lims oq

πŸ“‹ Description

  • Lead and execute validation activities for general releases, hot fixes, and revalidations.
  • Track, monitor, and control validation to meet release dates and budgets.
  • Provide regulatory interpretation and technical validation expertise.
  • Collaborate with Product Team to define clear, testable requirements.
  • Work with cross-functional teams to maintain the validated state of systems.
  • Ensure testing is risk-based and traceable.

🎯 Requirements

  • Bachelor's degree in Engineering/Sciences or equivalent.
  • 3+ years in CSV role.
  • Hands-on validation of enterprise apps (SAP, CTMS, LIMS, etc.).
  • Knowledge of 21 CFR 11/Annex 11; ISO 9001/ISPE guidelines.
  • Familiar with Agile, BA, and software testing methodologies.
  • Excellent written and oral communication.

🎁 Benefits

  • Medical, dental, vision, and basic life insurance.
  • Flexible PTO and company paid holidays.
  • Retirement programs.
  • 1% charitable giving program.
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