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Senior Validation Specialist

2 months ago

Cardiff, Cardiff, United Kingdom Proclinical Staffing Full time
Job Summary

We are seeking a highly skilled Validation Specialist to join our team at Proclinical Staffing. As a key member of our engineering team, you will be responsible for defining, executing, and reporting on validation activities related to facilities, utilities, and process equipment.

Key Responsibilities
  • Conduct IQ, OQ, and PQ studies to ensure optimal performance and output.
  • Develop, implement, and report on qualification, re-qualification, and validation studies to establish and maintain the validated status of facilities, utilities, equipment, and processes.
  • Apply a risk-based validation approach by participating in risk assessments using QRM principles and tools such as FMEA, HAZOP, etc.
  • Ensure risks are properly identified and documented.
Requirements
  • Previous experience in a pharmaceutical, biotech, cleanroom, or GMP environment.
  • Knowledge of current regulatory requirements and industry standards related to validation activities.
  • Basic knowledge of quality risk assessment principles and tools and their application in a risk-based qualification lifecycle.
What We Offer

We offer a dynamic and challenging work environment, opportunities for professional growth and development, and a competitive compensation package.