Senior Aseptic Training Specialist
Location: Portsmouth, NH, USA.
The Senior Aseptic Training Specialist acts as a vital business partner and Subject Matter Expert (SME) dedicated to maintaining a rigorous Quality Culture within the Asset. This role leads the development and execution of the aseptic behavior certification program, acts as the primary liaison with the Technical & GMP Training Department, and provides expert consultation on curriculum design. We seek an experienced leader passionate about training and committed to ensuring all personnel?including manufacturing, facilities, and cleaning staff?are properly trained prior to performance.
What will you get?
An agile career and dynamic working culture
An inclusive and ethical workplace
Compensation programs that recognize high performance
Comprehensive benefits including Medical, Dental, Vision, PTO, and more
The full list of our global benefits can be also found on .
What you?ll do:
Aseptic Program Ownership & Delivery: Administer and lead the hands-on delivery of the aseptic behavior certification program for all personnel working in the classified manufacturing environment.
Training & Curriculum Development: Act as the Asset?s Point of Contact (POC) and business SME for consulting on curriculum design for new or modified roles, and lead the development and delivery of GMP training modules related to proper aseptic behavior.
Quality Assurance & Improvement: Monitor Aseptic Process Simulation (APS) Media Fills and commercial runs to continuously improve existing training methodology and develop targeted training materials to address identified opportunities.
Coaching & Real-Time Reinforcement: Conduct regular GEMBA walks and observe gowning/entry procedures to reinforce correct aseptic techniques. Coach and mentor employees on maintaining low bio burden during interventions and runs.
Compliance & Technical Consultation: Maintain current working knowledge of cGMPs and emerging regulatory/compliance concerns related to sterile manufacturing. Provide aseptic technique support during smoke studies.
Deviation & CAPA Support: Support deviation investigations linked to microbial contamination (human factors) and related CAPAs. Contribute to action plans for employees showing alert limits in garment sampling to improve their technique.
Training System Liaison: Act as a liaison with the Technical & GMP Training Department regarding training content, delivery, and metrics, ensuring activities are accurately tracked in the Learning Management System (LMS).
What we?re looking for:
Aseptic Experience: 10+ years of experience in an aseptic environment or directly supporting aseptic manufacturing is preferred.
Leadership & Training: Training experience is essential. 2+ years of supervisory experience in an aseptic manufacturing environment is preferred.
Regulatory Expertise: Requires thorough working knowledge of GMPs, PICS, and ISO, with demonstrable expertise in sterile processing.
Communication & Project Skills: Must have the demonstrated ability to take complex principles and concepts and break them down into teachable elements. Proven ability to handle multiple projects in a dynamic environment.
About Lonza
At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who
we are and how we work together. Everyone?s ideas, big or small, have the potential to improve millions of lives, and that?s the kind of work we want you to be part of.
Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you?re ready to help turn our customers? breakthrough ideas into viable therapies, we look forward to welcoming you on board.
Ready to shape the future of life sciences? Apply now.
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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