Sr. Validation Engineer

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• Support a multi-phase validation project involving the reconfiguration of manufacturing Suites 5 & 6 and implementation of ADC production.
  

Job Description

• Support a multi-phase validation project involving the reconfiguration of manufacturing Suites 5 & 6 and implementation of ADC production.
  

Responsibilities

• Equipment decommissioning and clean room updates.
• Validation protocol generation, execution, and final certification.
• Facility readiness and compliance documentation.
• Summary reporting and archiving of validated materials.
  

Requirements

• Familiarity with cleanroom qualification and pharma equipment (Isolators, BSCs, skids).
• Knowledge/experience working with DeltaV systems.
• Strong grasp of change control and impact assessment procedures.
• Capable of executing smoke studies, HEPA certifications, and cleaning validations.
• Proven record managing documentation for audits and regulatory review.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Research Services

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