Data Validation Expert

12 hours ago


Abingdon, Oxfordshire, United Kingdom Replimune, Inc. Full time
Job Summary

The Validation Engineer II will play a crucial role in ensuring the biotech facility equipment, utilities, instrumentation, and computerized systems are qualified and maintained in a validated state in accordance with relevant regulatory guidance.

  • Develop and execute qualification protocols and reports, including acceptance criteria generation.
  • Manage vendors and contractors performing qualification activities.
  • Oversee projects associated with computerized equipment and computer system validation (CSV).
  • Conduct data integrity assessments to ensure compliance.
  • Maintain equipment and building monitoring systems in validated compliance.
  • Prioritize responsibilities include supporting design, procurement, installation, commissioning, and qualification of utilities and equipment for new equipment and facility expansion projects.
Key Responsibilities
  1. Ensure all work is performed in accordance with Standard Operating Procedures (SOPs), Current Good Manufacturing Practices (cGMP), quality standards, and safety procedures.
  2. Collaborate with internal and regulatory agency teams during audits and inspections.
  3. Ensure training remains GMP compliant.
Requirements

Bachelor's degree in Scientific, Engineering, or similar field required; Master's preferred.

A minimum of five years of professional experience in validation, engineering, or operations.



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