Bioburden/Contamination Control Lead

Spain, Porrino

Today Lonza is a global leader in life sciences. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Bioburden/Contamination Control Lead will lead and oversee all aspects of the bioburden control program to be deployed in the site. Pulling together key stakeholders while working closely with the Global Head, the senior expert will focus on the bioburden control culture, operations and awareness to meet goals of success rate in Porriño.  The Bioburden/Contamination Control Lead will lead the local awareness contamination team (ACT).  Additionally the new role will indirectly report into the Global Head of Microbial control in an ongoing effort to harmonize best bioburden control practices across the network.

Key responsibilities:

  • Accountable for the compliant, effective and modern bioburden control strategy on site
  • Will build an aseptic education and awareness-training program at the local level to ensure aseptic sustainability in collaboration with Lonza Academy.
  • Builds and leads a Contamination Awareness Team (ACT) of Aseptic Subject Matter Experts (SMEs) to serve the local site that will deliver aseptic awareness training and lead identified initiatives in an ongoing effort to achieve vision zero.
  • Review of facility design, zone concepts and managing changes to meet global and regulatory requirements.
  • Works closely with Microbiology and Facilities to ensure robust facilities cleaning program (procedures and frequency).
  • Frequently performs global review and alignment on best practice toward vision zero objective.
  • Leads cross-functional/site review and update local documents.
  • Design an effective and sustainable communication platform at the site level that can be clearly reported to the global network.
  • Site SME in front of regulatory or customer audits in the field of bioburden control.

Key requirements:

  • Bachelor of Science, Science Related Field
  • Good command of written and spoken English - Business Fluent
  • Advanced experience of USP and EP, Endotoxin, and Sterility Testing
  • Strong regulatory understanding of environmental monitoring programs that can will enable proactive assessment of controls prior to exceeded action limits.
  • Technical knowledge of clean room engineering including particle control mechanisms.
  • Strong experience in building, developing and leading indirect teams.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference

Reference: R37869