Aseptic Training Specialist at US02 Lonza Biologics Inc. in Portsmouth, New Hampshire

Posted in Health Care 24 days ago.

Type: Full-Time





Job Description:

 

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 Aseptic Training Specialist is responsible for collaborating with Manufacturing, Technical & GMP Training, Quality Assurance, and Quality Control to develop role appropriate training plans for manufacturing personnel.  The incumbent tracks employees’ progression to plan, reports metrics, and ensures that activities are appropriately tracked in the LMS.  Other key responsibilities include developing area trainers capable of effective knowledge transfer as well as overseeing individual Aseptic Process Simulations.  This position is a vital business partner who is passionate about training & committed to excellence while ensuring Asset’s personnel are properly trained prior to performance. 

Key Responsibilities:


  • Collaborates with supervisors and support staff to develop and execute role appropriate training plans for manufacturing personnel.

  • Acts as the Asset liaison with the Technical & GMP Training Department regarding training completion and training compliance metrics/KPIs and ensures that activities are appropriately tracked in the LMS.

  • Provides hands-on training for aseptic behavior inside the aseptic/classified manufacturing areas. 

  • Provides training on other unit operations as required.

  • Works with leadership to identify and develop area trainers.

  • Ensures consistency in content and quality of trainings delivered by area trainers. 

  • Ensures consistent application of gowning and aseptic techniques by supporting routine re-qualification and ad-hoc observation of aseptic applications.

  • Monitor Aseptic Process Simulation (APS) media fills and commercial runs to continuously improve existing training methodology and develop training materials to address those opportunities.

Key Requirements:


  • Bachelor's in Life Sciences or related field  required

  • 5+ years of experience in a regulated/ compliant pharmaceutical or biotechnology production environment; aseptic experience 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. 





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