Biopharmaceutical Validation Engineer

4 days ago


Cardiff, Cardiff, United Kingdom Ipsen Biopharm Ltd Full time

Ipsen Biopharm Ltd is a dynamic and growing specialty-driven biopharmaceutical company focused on innovation and patient care. We are committed to attracting and developing bold, agile, and entrepreneurial individuals who take ownership of their decisions and make a direct impact through their work in people's lives.

The role of Validation Specialist at Ipsen offers a unique opportunity to support the engineering team in defining, executing, and reporting on validation maintenance activities for facilities, utilities, and process equipment. As part of our expanding operations, you will be involved in the qualification and re-qualification of various systems to ensure optimal performance and output.

Key Responsibilities:
  • Define and Execute Qualification Studies: Develop and implement qualification plans to maintain the qualified status of facilities, utilities, equipment, and processes according to internal procedures, regulatory requirements, and industry standards.
  • Subject Matter Expertise: Provide subject matter expertise on specific validation activities as defined by the Qualification and Calibration Manager, including presenting packages to internal and external auditors.
  • Investigation and Resolution of Non-Conformances: Investigate and resolve non-conformances encountered during re-qualification and periodic review activities with senior validation team members' support.
  • Risk-Based Validation Approach: Contribute to a risk-based validation approach by participating in risk assessments using QRM principles and tools like FMEA and HAZOP to identify and document risks.
  • Continuous Improvement Initiatives: Identify and implement lean working practices to improve efficiency and effectiveness.
Requirements:
  • Prior experience in pharmaceutical/biotech/cleanroom/GMP environments.
  • Familiarity with validation lifecycles.
  • Knowledge of current regulatory requirements and industry guidance/standards related to validation activities.
  • Experience in executing qualification and validation activities, including IQ, OQ, and PQ.
  • Understanding of quality risk assessment principles and tools, including FMEA and HAZOP.
  • Competency in generating and reviewing technical documentation.
About Ipsen and Wrexham:
  • We are currently experiencing exponential growth and change, offering exciting challenges and opportunities.
  • A major investment in a New Drug Product Facility will increase the scale and capability of our Wrexham site, enhancing the products we develop for our customers.
  • We have a fantastic culture and working environment with many long-serving employees.
  • Huge commitment to Diversity & Inclusion, with almost 50% of our top leaders being women.
  • A genuine focus on the environment and sustainability, with our Wrexham site powered by 100% renewable electricity.
  • Competitive salaries and an enhanced benefits package, including annual bonuses, a generous pension scheme, wellness allowance, and more.
  • Awarded 'Best Workplaces' and 'Best Workplaces for Wellbeing' status in the Large Organisations category, as well as 'Best Workplaces for Women' in 2023.
  • The pride of working for a company that directly impacts and changes lives for the better.


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