Microbial Control Site Lead

United States, Hayward (California)

Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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.

The Microbial Control Site Lead oversees all aspects of the microbial control program improving on the overall strategy. Pulling together key assets while working closely with the Global Head, the site head will focus on the microbial control culture, operations and awareness.

Key responsibilities:

  • ​Accountable for the compliant, effective and modern contamination control strategy
  • Will build an aseptic education and awareness-training program at the local level to ensure aseptic sustainability.
  • Builds a team of Aseptic Subject Matter Experts (SMEs) to serve the local site that will deliver aseptic awareness training in an ongoing effort to achieve vision zero.
  • Review of facility design, zone concepts and managing changes to meet global and regulatory requirements.
  • Frequently performs global review and alignment on best practice toward vision zero objective.
  • Leads cross-functional/site review and update local documents.
  • Must be able to perform and understand systemic review of system setup and sanitization across all assets to ensure compliance to microbial control.
  • Works with the Global Head of Microbial Contamination Control reviewing and aligning on best practice towards vision zero objective.
  • Create general facility and standard Risk Assessment (RA) to harmonize standards across the site assets to ensure uniformity with the ability to articulate technical aspects of completed RA to the Global Network.
  • Supports local solution efficacy studies in line with the Global strategy. Develop, implement and continuously improve a useful and executable contamination control guidelines taking unique customer and diverse Lonza requirements into consideration in line with current regulations and industry standards.
  • Tracks related Key Performance Indications (KPIs) and own the response to improve performance.
  • Design an effective and sustainable communication platform at the site level that can be clearly reported to the global network.
  • Establish clear lines of communication between assets to ensure events and lessons learned are shared on a local and global platform.

Key Requirements:

  • BS in Microbiology or Science Related Field
  • Advanced years’ experience in pharma/biopharma industry with emphasis in microbiology experience
  • Hands-on attitude in working together with internal assets in both reactive and pro-active contamination control
  • Hands-on experience in complex investigations in both preventive and reactive contamination control
  • Knowledge and experience in microbiological test technologies, efficacy studies and recovery methods.
  • 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

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this not only a great privilege, but also a great responsibility.  How we achieve our business results is just as important as the achievement 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.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

Reference: R25150