Validation Engineer III

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

• 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

• 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

Take the leap and apply today.