Aseptic Training Specialist (First Shift)
Aseptic Training Specialist – Cell Therapy
Location: Portsmouth, NH, USA
Schedule: Day Shift, 4-Day, 10-hour shift (0600 – 1530). Specific days to be confirmed by the Hiring Manager.
About the role
We are seeking a high-performing internal candidate to join our leadership fabric in Portsmouth, NH, as an Aseptic Training Specialist. This strategic "step-up" role is responsible for the technical mentorship of our manufacturing teams, acting as a Subject Matter Expert (SME) to ensure all personnel are masters of the aseptic craft. The ideal candidate must be a recognized role model for aseptic behavior, possess a passion for coaching, and be committed to driving a "Quality First" culture across the Cell Therapy asset.
Responsibilities
- Aseptic Certification & Training: Administer and lead the aseptic behavior certification program for all employees entering manufacturing environments, including facilities and cleaning staff.
- Shop-Floor Coaching: Conduct regular GEMBA walks and real-time observations to reinforce correct gowning and aseptic techniques among the production teams.
- Hands-on Mentorship: Act as the primary hands-on trainer inside classified/aseptic manufacturing areas, transitioning complex theory into flawless floor execution.
- Process Monitoring: Monitor Aseptic Process Simulations (APS) and commercial runs to identify training gaps and continuously improve existing methodologies.
- Curriculum Development: Act as the Asset’s POC for consulting on curriculum development for new roles, OJT materials, and cross-asset training projects.
- Investigation Support: Provide "Human Factor" expertise during microbial deviation investigations, assisting in the development of action plans to improve team technique.
- Regulatory & Audit Support: Serve as a technical SME during regulatory inspections (FDA, EMA) and maintain an elite knowledge of emerging cGMP aseptic standards.
Requirements
- Proven technical mastery in Grade B cleanroom environments and a flawless personal record of aseptic interventions.
- Leadership Traits: Recognized by peers as an "Aseptic Role Model" with the courage to provide honest, constructive feedback to drive behavioral change.
- Coaching Ability: A natural passion for teaching and the ability to mentor others in a way that fosters excellence rather than policing.
- Integrity: A deep, uncompromising commitment to the GMP mindset and the promotion of a site-wide Quality Culture.
Qualifications
- High School Diploma or equivalent is required.
- AS/BS in Science-related fields is preferred.
Benefits
Compensation programs that recognize high performance
Medical, dental and vision insurance, as well as PTO and more
Our full list of global benefits can be found here: https://www.lonza.com/careers/benefits
Pay
Commensurate with experience
Schedule
4-Day, 10-hour shift (0600 – 1530)
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