Validation Expert

3 weeks ago

Wrexham, Wrexham, United Kingdom Meet Full time
About the Role:

In this key position, you will play a vital role in supporting our engineering team by leading and executing validation activities across facilities, utilities, and process equipment.

You will be responsible for performing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) studies, ensuring compliance with regulatory standards and optimizing performance.

Key Responsibilities:

  • Lead qualification, requalification, and validation studies for facilities, utilities, and equipment.
  • Act as a Subject Matter Expert for validation activities, collaborating closely with cross-functional teams.
  • Investigate and resolve non-conformances related to validation, with support from senior team members.
  • Contribute to risk assessments using tools such as Failure Mode and Effects Analysis (FMEA) and Hazard and Operability (HAZOP) studies, applying a risk-based approach to validation.
  • Implement continuous improvement initiatives to enhance validation processes.

Requirements:

  • Previous experience in a pharmaceutical, biotech, or Good Manufacturing Practice (GMP) environment.
  • Strong understanding of validation and qualification processes (IQ, OQ, PQ).
  • Familiarity with current regulatory requirements and industry standards.
  • Experience with technical documentation, including generating and reviewing validation reports.
  • Basic knowledge of risk management tools and their application in validation.

Why Meet:

  • Exciting Projects: Be part of our major investment in new Drug Product facilities, offering unique and exciting challenges.
  • Competitive Benefits: We offer a generous benefits package, including annual bonuses, a robust pension scheme, wellness allowances, and more.
  • Diverse and Inclusive Workplace: We are committed to diversity, sustainability, and the wellbeing of our employees. With a proven track record of being recognized as one of the best workplaces for women and wellbeing, we value and celebrate our diverse team.
  • Impactful Work: Your efforts will directly contribute to advancing healthcare solutions and improving lives.

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