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Validation Expert

2 months ago

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

We are seeking a highly skilled Validation Specialist to join our team at Meet, a leading specialty-focused biopharmaceutical company. As a Validation Specialist, you will play a critical role in ensuring the quality and integrity of our products and processes.

Key Responsibilities
  • Lead Qualification and Validation Activities: You will be responsible for leading and executing qualification and validation activities across facilities, utilities, and process equipment, ensuring compliance with regulatory standards and optimizing performance.
  • Subject Matter Expert: You will serve as a subject matter expert for validation activities, collaborating closely with cross-functional teams to ensure seamless execution and effective communication.
  • Investigate and Resolve Non-Conformances: You will investigate and resolve non-conformances related to validation, working closely with senior team members to ensure timely and effective resolution.
  • Contribute to Risk Assessments: You will contribute to risk assessments using tools such as FMEA and HAZOP, applying a risk-based approach to validation to ensure the highest level of quality and safety.
  • Implement Continuous Improvement Initiatives: You will identify opportunities for process improvements and implement initiatives to enhance validation processes, ensuring continuous learning and growth.
Requirements
  • Previous Experience: You must have previous experience in a pharmaceutical, biotech, or GMP environment, with a strong understanding of validation and qualification processes.
  • Regulatory Knowledge: You must have a strong understanding of current regulatory requirements and industry standards, with the ability to apply this knowledge in a practical and effective manner.
  • Technical Documentation: You must have experience with technical documentation, including generating and reviewing validation reports, with a strong attention to detail and ability to communicate complex information effectively.
  • Risk Management: You must have basic knowledge of risk management tools and their application in validation, with the ability to apply this knowledge in a practical and effective manner.
Why Meet?
  • Exciting Projects: You will have the opportunity to work on exciting projects, including the development of new Drug Product facilities, offering unique and challenging opportunities for growth and development.
  • Competitive Benefits: We offer a comprehensive 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.
  • Impactful Work: Your efforts will directly contribute to advancing healthcare solutions and improving lives, making a real difference in the world.