Principal Validation Engineer - Juncos, PR

Only for registered members Juncos, PR , United States

4 days ago

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Job summary

We are seeking a Principal Validation Engineer to join our team. The ideal candidate will have a Bachelor's Degree and eight years of experience as a senior Engineer in the pharmaceutical or regulated industry.
Bilingual (English & Spanish) with Project Management skills and experience in developing and approving IQ, OQ, PQ, requalification, and validation maintenance strategies for autoclaves and SIP systems.
The successful candidate will be responsible for reviewing lifecycle documents including User Requirements, Risk Assessments Data Integrity Assessments Commissioning Qualification Plans Validation Plans Installation Operational Performance Verification protocols reports supporting field execution commissioning integration testing evaluating protocol discrepancies deviations participating engineering design phases proposing modification qualification strategies creating revising SIP drawings applying risk-based validation approaches participating project weekly meetings assessing potential hazards implementing appropriate controls providing SME support engineering phases align commissioning execution strategy CQ Service Provider ensuring qualification strategies address worst-case conditions load patterns critical process parameters ensuring qualification impact proposed critical system changes through Change Control Program if necessary.
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