Aseptic Training Specialist

Netherlands, Geleen

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.

We are looking for an Aseptic Training Specialist to join our Operational Excellence team at Lonza Geleen. The Aseptic Training Specialist is responsible for supporting excellence in aseptic behavior at the site. Responsibilities encompass providing and coordinating on-boarding training related to Aseptic behavior, but also monitoring aseptic behavior and providing appropriate coaching and retraining. The Aseptic Training Specialist is Subject Matter Expert on aseptic behavior and provides input on procedural revisions, equipment or project implementation where needed.

Key responsibilities:

  • Provides know how and support to the organization in defining adequate aseptic procedures. Expert in design of cleanrooms, furnishings and equipment in cleanrooms to be appropriate design and cleanable.
  • Hands-on trainer for aseptic behavior inside the aseptic/classified manufacturing areas while analyzing trends to implement solutions.
  • Administer aseptic behavior certification program for employees working in the manufacturing aseptic environment and audit employees entering aseptic environment on a daily basis. Ensure compliance with gowning and aseptic techniques. Evaluate and develop action plans for employees showing alert limits in garment sampling.
  • Monitor manufacturing runs to identify additional training needs and develop training materials to address those opportunities.
  • Provide aseptic technique support during smoke studies.
  • Provide support for cleanroom management including ensuring cleaners are properly trained and monitored, cleaning procedures are appropriate.
  • Generate reports and trend analyses supporting both Manufacturing & QA Management.
  • Develop and deliver GMP training modules related to proper aseptic behavior and maintaining an aseptic environment.
  • Maintain working knowledge of cGMPs and emerging regulatory and compliance concerns as related to sterile manufacturing. Assess equipment and 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.
  • Facilitate and or support risk assessments to further improve current practices
  • Support audits on aseptic procedures, trending, risk assessments,…
  • Evaluate from the aseptic perspective any equipment modification, process changes, new equipment or tools to be introduced inside the aseptic area.

Key requirements:

  • Bachelor in scientific field with work experience in GMP manufacturing
  • Self-starter, excellent written and verbal communicator at all levels, able to tolerate challenging workload and changing priorities, attention to detail, work effectively and individually and with teams.
  • Knowledge of the global regulatory guidelines affecting the pharmaceutical industry.
  • Uses broad expertise or unique knowledge and skills to contribute to the training development of company objectives and principles, and to achieve goals in creative and effective way.
  • Identifies and implement methods, techniques, procedures and evaluation criteria to achieve results.
  • Experience in delivering GMP training, and with electronic GxP training electronic platforms.
  • Strong coordinator and team player.

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: R39111