Training Specialist (Aseptic)

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).  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.  The Aseptic Training Specialist is a role model in the organization, understanding and promoting an aseptic mindset and behaviors that drive a quality culture.

Key responsibilities:

  • Administer aseptic behavior certification program for employees working in the manufacturing aseptic environment including supporting cleaning staff, facilities staff etc.
  • Hands-on trainer for aseptic behavior inside the aseptic/classified manufacturing areas
  • Monitor Aseptic Process Simulation (APS) Media Fills and commercial runs to continuously improve existing training methodology and develop training materials to address those opportunities.
  • Provide aseptic technique support during smoke studies.
  • Develop and deliver GMP training modules related to proper aseptic behavior and maintaining an aseptic environment.
  • Coach and mentor employees on the importance of maintaining low bio burden during line clearing/cleaning, runs, routine and non- routing interventions.
  • Contribute with MFG and QA to develop action plans for employees showing alert limits in garment sampling to improve technique
  • Maintain working knowledge of cGMPs and emerging regulatory and compliance concerns as related to sterile manufacturing. Assess work environment to ensure it is suitable to enable good aseptic behaviors and makes recommendation to management on changes needed.
  • Support deviation investigations linked to microbial contamination and their relative CAPA’s related to human factors

Key requirements:

  • Requires Bachelor's Degree in a scientific field, such as Microbiology
  • Experience in an aseptic environment or supporting aseptic manufacturing preferred.
  • Several years of supervisory experience in an aseptic manufacturing environment preferred
  • Training experience is essential
  • Strong oral, written, communication, presentation and interpersonal skills.
  • The position is self-directed and requires an appropriate level of education, experience and confidence.
  • 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.

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: R43962