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

🎯 Requirements

Bachelor's degree in Engineering/Sciences or equivalent.
3+ years of experience in a CSV role.
Hands-on validation of enterprise apps (e.g., SAP) in regulated activities.
Strong knowledge of 21 CFR 11, Annex 11, ISO 9001, ISPE guides.
Familiarity with Agile software development and testing.
Excellent written and verbal communication skills.

🎁 Benefits

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

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