Senior Validation Specialist

4 weeks ago


Bangor, Gwynedd, United Kingdom Proclinical Staffing Full time

Job Title: Senior Validation Specialist

Job Summary:

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

Key Responsibilities:

  • Develop, implement, and report on qualification, re-qualification, and validation studies to establish and maintain the validated status of facilities, utilities, equipment, and processes in accordance with internal procedures, regulatory requirements, and industry standards.
  • Act as the Subject Matter Expert for specific validation activities as designated by the Qualification and Calibration Manager.
  • Investigate and resolve non-conformances found during requalification, revalidation, and periodic review activities, with support from senior validation team members.
  • Apply a risk-based validation approach by participating in risk assessments using QRM principles and tools such as FMEA, HAZOP, etc., ensuring risks are properly identified and documented.
  • Identify and implement Continuous Improvement initiatives to promote lean processes.

Key Requirements:

  • Previous experience in a pharmaceutical, biotech, cleanroom, or GMP environment.
  • Strong understanding of qualification and validation lifecycles.
  • Knowledge of current regulatory requirements and industry standards related to validation activities.
  • Proven experience in executing qualification and validation tasks such as IQ, OQ, PQ.
  • Technical, compliance, and practical knowledge of specific validation activities, as guided by the Validation Manager.
  • Basic knowledge of quality risk assessment principles and tools and their application in a risk-based qualification lifecycle.
  • Proficient in creating and reviewing technical documentation.


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