Aseptic Training Specialist

United States, Portsmouth (New Hampshire)

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.

The Cell Therapy Aseptic Training Specialist is responsible for aseptic manufacturing programs regarding training content, delivery, and metrics as well as ensuring that activities are appropriately tracked in the LMS.  The Aseptic Training Specialist role provides technical proficiency and consultative guidance as an aseptic subject matter expert (SME) in the creation of on-the-job training materials.  This position is a vital business partner who is passionate about training & committed to aseptic compliance while ensuring asset’s personnel are properly trained prior to performance.  The incumbent collaborates with all levels of Cell Therapy Manufacturing to confirm aseptic training plan objectives are met through effective learning and training solutions.  They serve as the asset’s POC (Point of Contact) for consulting on improving aseptic control measures and related projects. 

Hours: Monday-Friday 8AM-4:30PM

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.
  • Owns and maintains LPO documents pertaining to aseptic practices in manufacturing.
  • Monitor Aseptic Process Simulation (APS) media fills and commercial runs to continuously improve existing training methodology and develop training materials to address those opportunities.
  • Provides hands-on for aseptic behavior inside the aseptic/classified manufacturing areas. 
  • 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:

  • Intermediate experience in an aseptic environment or supporting aseptic manufacturing preferred.
  • Supervisory experience in an aseptic manufacturing environment 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: R30567