Senior Validation and Verification Specialist

3 weeks ago


Cardiff, Cardiff, United Kingdom Proclinical Staffing Full time
Job Title: Senior Validation and Verification Engineer

Proclinical Staffing is seeking a highly skilled Senior Validation and Verification Engineer to join our team. As a key member of our engineering team, you will be responsible for supporting the development, implementation, and reporting of validation activities related to facilities, utilities, and process equipment.

Key Responsibilities:
  1. Develop and implement 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.
  2. Act as the Subject Matter Expert for specific validation activities as designated by the Qualification and Calibration Manager.
  3. Investigate and resolve non-conformances found during requalification, revalidation, and periodic review activities, with support from senior validation team members.
  4. 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.
  5. Identify and implement Continuous Improvement initiatives to promote lean processes.
Key Requirements:
  1. Previous experience in a pharmaceutical, biotech, cleanroom, or GMP environment.
  2. Strong understanding of qualification and validation lifecycles.
  3. Knowledge of current regulatory requirements and industry standards related to validation activities.
  4. Proven experience in executing qualification and validation tasks such as IQ, OQ, PQ.
  5. Technical, compliance, and practical knowledge of specific validation activities, as guided by the Validation Manager.
  6. Basic knowledge of quality risk assessment principles and tools and their application in a risk-based qualification lifecycle.
  7. Proficient in creating and reviewing technical documentation.


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