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Validation Specialist

2 months ago

Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Danaher Full time

Leica Biosystems' mission of "Advancing Cancer Diagnostics, Improving Lives" is at the heart of our corporate culture. We're a global leader in cancer diagnostics with the most comprehensive portfolio from biopsy to diagnosis. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. Our associates know that every moment matters when it comes to cancer diagnostics. When you come to work, you're helping develop solutions that enable accurate diagnoses to turn anxiety into answers. Join our diverse, global team of talented people, and be inspired to grow every day.

Leica Biosystems is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we're working at the pace of change to improve patient lives with diagnostic tools that address the world's biggest health challenges.

The Validation Specialist for Leica Biosystems is responsible for the validation and qualification of manufacturing equipment, software, and processes, as well as delivering process improvements, capacity expansions, and cost savings while meeting applicable regulatory standards.

This position is part of the Advanced Staining Reagents business unit located in Newcastle, UK and will predominantly be an on-site role. At Leica Biosystems, our vision is to advance cancer diagnostics and improve lives.

You will be a part of the Process Development team and report to the Technical Team Leader – Process Development responsible for delivering high quality validation and process improvements within the wider Operations department. If you thrive in a fast-paced, multifunctional role and want to work to build a world-class Operations and Manufacturing organization—read on.

In this role, you will have the opportunity to:

  • Introduce new operational equipment, software, and processes through the development of end-user requirements, validation protocols, and appropriate procedures / standard work.
  • Drive commissioning & validation projects to completion by working collaboratively with other departments across site.
  • Execute required validation and qualification testing to a high standard ensuring results are recorded accurately and legibly to required GDP standards.
  • Analyse existing processes and workflows within Operations through data gathering and Gemba visits to determine process improvements that can be made to remove waste and aid the business in meeting site KPI and daily metric targets.
  • Promote, support, and execute the use of DBS Fundamental and Lean tools to drive root cause analysis and continuous improvement within Operations and Manufacturing.

The essential requirements of the job include:

  • Educated to HND / degree level in an engineering or science related discipline.
  • Proven background working within a regulated / cGMP manufacturing industry e.g., pharmaceutical / medical device.
  • Authoring of technical validation, qualification documents and reports i.e. VMP / URS / IQ / OQ / PQ.
  • Executing qualifications and validation of manufacturing equipment, software, and processes.

It would be a plus if you also possess previous experience in:

  • Using continuous improvement methodologies and tools to drive results.
  • Working with 3rd parties and internal customers to investigate, implement, and validate new and novel equipment and processes.
  • Quality management system processes such as change control, deviations and CAPAs as required by regulations such as ISO 9001, ISO 13485, and 21CFR Part 820.

At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what's next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.