Minimum 5 years of experience in the life sciences industry
Strong knowledge of Computerized Systems Validation (CSV)
Experience drafting validation lifecycle documents (Validation Plans, IQ / OQ / PQ protocols, RTM, VSR)
Proficient in deviation and change management processes
Familiarity with project management principles
Solid understanding of 21 CFR Part 11 regulations
Experience validating laboratory instruments
Skilled in IT collaboration and troubleshooting
Adept at requirements gathering and root cause analysis
Local candidate required for hybrid on-site / remote work
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Validation Engineer • Summit, NJ, United States
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