Aseptic Training Specialist (Nights)

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.

Check out this video about what a career at our Portsmouth NH facility could look like for you: Your Career with Lonza in Portsmouth, NH (youtube.com)

ROLE RESPONSIBILITIES:

• Administer aseptic behavior certification program for employees working in the manufacturing aseptic environment including supporting cleaning staff, facilities staff etc.
• Conduct regular GEMBA walks and observe employees entering aseptic environment to  re-enforce correct gowning and aseptic techniques are consistently executed
• 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

QUALIFICATIONS:

• Requires Bachelor's Degree in a scientific  field, such as Microbiology•10+ years of experience in an aseptic environment or supporting aseptic manufacturing preferred.
• 2+ 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 confidenc.
• 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.