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Validation Expert

2 months ago

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

We are seeking a skilled Validation Specialist to join our team and support our engineering department in leading and executing validation activities across facilities, utilities, and process equipment.

As a Validation Specialist, you will be responsible for performing IQ, OQ, and 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 FMEA and HAZOP, applying a risk-based approach to validation.
  • Implement continuous improvement initiatives to enhance validation processes.
Requirements
  • Previous experience in a pharmaceutical, biotech, or 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.