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Senior Validation Specialist

2 months ago

Cardiff, Cardiff, United Kingdom Proclinical Staffing Full time
Validation Specialist Job Description

As a key member of our engineering team, you will play a crucial 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.

We are expanding our capabilities with the addition of a new Drug Product facility, and we are seeking a skilled Validation Specialist to join our team.

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.
  • 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.

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.