Senior Training Specialist
About The Position
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 https://www.lonza.com/careers/benefits .
Requirements
- 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.
Responsibilities
- 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).
Benefits
- 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 https://www.lonza.com/careers/benefits
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
Number of Employees
5,001-10,000 employees
