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Senior Validation Specialist

2 months ago

Cardiff, Cardiff, United Kingdom Proclinical Staffing Full time
Job Title: Senior Validation Specialist

As a key member of our engineering team, you will play a critical role in supporting the validation of facilities, utilities, and process equipment. Your primary focus will be on defining, executing, and reporting on validation activities to ensure optimal performance and output.

Key Responsibilities:
  • Conduct IQ, OQ, and PQ studies to establish and maintain the validated status of facilities, utilities, equipment, and processes.
  • Develop, implement, and report on qualification, re-qualification, and validation studies in accordance with internal procedures, regulatory requirements, and industry standards.
  • Apply a risk-based validation approach by participating in risk assessments using QRM principles and tools such as FMEA, HAZOP, etc.
  • Collaborate with cross-functional teams to ensure risks are properly identified and documented.

Previous experience in a pharmaceutical, biotech, cleanroom, or GMP environment is required. Knowledge of current regulatory requirements and industry standards related to validation activities is essential. Basic knowledge of quality risk assessment principles and tools and their application in a risk-based qualification lifecycle is also necessary.

What We Offer:
  • A dynamic and supportive work environment.
  • Opportunities for professional growth and development.
  • A competitive salary and benefits package.