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Validation Engineer III

Scorpion Therapeutics

What You’ll Do Lead key deliverables in a phase‑appropriate compliance manner as part of global CQV strategy for Facilities & Utilities, Equipment, QC/Analytical, Cleaning and Shipping Document validation program strategy, including generation of validation master plans Liaise with equipment, operations, logistics, QC, tech transfer, process development teams, and third‑party contractors to define and perform cycle development, qualification, and validation activities Author validation documentation (risk/gap assessments; cycle development protocols/reports/procedures; qualification/validation protocols and reports; validation discrepancies) Lead validation discrepancy resolution (troubleshooting and root cause analysis) Support development of qualification/validation programs, including transitioning from paper‑based to digital validation software and scalable end‑to‑end paperless solutions Develop and strategize compliant and novel ways to meet regulatory requirements Support inspection readiness, Health Authority/Client audits, and corrective actions Lead CQV activities across global expansion sites Who You Are Bachelor’s degree in engineering science or related program; Validation Engineer III: 7+ years relevant experience Science- and risk‑based qualification approach; industry standards and best practices Working knowledge of US FDA CFRs and European EMA, including ICH regulations Experience with quality risk management Experience authoring/reviewing/approving validation documentation Knowledge of process equipment, utilities, operations, and engineering principles; strong quality focus and attention to detail Problem‑solving/critical thinking; self-starter with mechanical aptitude Ability to work independently and collaboratively across disciplines; strong interpersonal and communication skills; strong task/time management Additional Qualifications Applies expertise to solve complex technical problems; significant contributor to multidisciplinary teams; led teams/large validation projects Working knowledge of shipping/cleaning, process validation, utilities/facilities, computerized systems, analytical equipment/systems Application Instructions Take the leap and apply today. #J-18808-Ljbffr Scorpion Therapeutics

Vacancy posted 1 day ago
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