Aseptic Training Specialist

United States, Houston (Texas)

Today, Lonza is a global leader in life sciences operating across three continents. 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.

Lonza Houston’s Cell and Gene Therapy Facility is the largest in the world and our facility is growing. We are looking for professionals to grow with us and we have this exciting opportunity in the Operational Excellence Group.  The Lonza Houston site is undergoing an effort to boost their Aseptic Training team by the implementation of a new role of Aseptic Training Specialist.  The Aseptic Training Specialist will focus on supporting and training internal personnel for Aseptic Techniques to  function in the operations and manufacturing groups.

Key responsibilities:

  • Maintains familiarity with global policies and procedures as well as regulatory and industry trends.  Is able to effectively incorporate these at the site level.
  • Utilizes input from network and other site SMEs to develop policies and procedures appropriate for the operations group.
  • Leads tactical projects in support of aseptic strategic initiatives.
  • Conducts regular gemba walks and observe employees entering aseptic environment to re-enforce correct gowning and aseptic techniques are consistently executed.
  • Monitor Aseptic Process Simulation (APS) media fills and commercial runs to continuously improve existing training methodology and develop training materials to address those opportunities.
  • Administers aseptic behavior certification program for employees working in the manufacturing aseptic environment including supporting cleaning staff, facilities staff etc.
  • Supports investigations, CAPAs, and Change Controls pertaining to microbial contamination or shortcoming in aseptic technique

Key requirements:

  • Bachelor degree preferred in a technical field Combinations of education and experience considered, with Certificate
  • Relevant experience in biotech work environment
  • Relevant Biotech manufacturing experience
  • Ability to work in a fast-paced environment
  • Intermediate  experience in an aseptic environment or supporting aseptic manufacturing preferred.
  • Training experience is essential
  • Requires thorough/working knowledge of GMP's, PICS and ISO and expertise in sterile processing. Must have demonstrated ability to handle multiple projects in a dynamic environment.
  • Must be able to take complex principles and concepts and break them down into teachable elements so colleagues can quickly understand.

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.

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: R31970