Aseptic Training Specialist
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 Cell and Gene Therapy facility, located in Houston, Texas, is the largest in the world and our facility is growing. We are looking for a Aseptic Training Specialist who will be responsible to provide technical and Good Manufacturing Practice (GMP) training proficiency and consultative guidance to Assets and/or Functional Groups in aseptic practices and techniques. Aseptic Training Specialist will collaborate with supported Asset and/or Functional Group to ensure business objectives are met through effective learning and training solutions. Applies adult learning and instructional design in the development and delivery of training modules. Other duties include: management of quality records, revision of GMP records, investigations and Corrective and Preventative Actions (CAPAs). Aseptic Training Specialist will play as a role model in the organization, understanding and promoting a GMP mindset and behaviors that drive a Quality Culture.
Provides hands-on training for aseptic behavior inside the aseptic/classified manufacturing areas.
Administers gowning qualification and aseptic behavior certification program for employees working in the manufacturing aseptic environment including supporting cleaning staff, Quality Assurance and Quality Control groups, facilities staff, etc.
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 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.
Supports investigations, CAPAs, and Change Controls pertaining to microbial contamination or shortcoming in aseptic technique
Perform other duties as assigned.
Bachelor’s Degree in Life Sciences, Engineering field, or Biotechnology
GMP compliance knowledge
Cell culture, molecular biology or biotech/biopharma laboratory and/or manufacturing experience, preferably in a cGMP manufacturing environment
Effective communication skills (written and oral communication)
Computer software skills (ie LMS, TrackWise, Microsoft Office (PowerPoint, Excel, etc.)
Demonstrated experience with the ADDIE model, or similar training development model
Technical writing and presentation skills
Excellent attention to detail
Understanding and practice of GxP
Organizational, strategic planning and time-management
Ability to multitask and handle multiple projects
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.