Technical Trainer - Large Scale Allogenic Manufacturing

Lonza•Portsmouth, NH

13d•Onsite

About The Position

We are seeking a highly proficient technical authority to join our Cell Therapy Manufacturing organization in Portsmouth, NH, as a Technical Trainer. Operating under general supervision, this specialized role acts as the primary asset partner and business Subject Matter Expert (SME) dedicated to supporting our brand-new Large Scale Allogeneic (LSA) project. You will bridge the gap between operations and the core technical training department—administering behavior certifications, developing on-the-job training (OJT) modules, and delivering hands-on coaching within classified environments to champion a bulletproof GxP quality culture.

Requirements

5–8 years of advanced experience within an aseptic manufacturing environment or supporting sterile processing lines is required.
Proven background delivering technical instruction or acting as a Technical Trainer or OJT instructor is required.
Thorough working knowledge of cGMP, PIC/S, and ISO regulations relating to sterile drug product processing and environmental monitoring frameworks.
Exceptional capacity to break down complex scientific protocols, standard operating procedures, and cleanroom physics into accessible, teachable elements for rapid trainee comprehension.

Nice To Haves

A timeline of 10+ years of direct aseptic cleanroom exposure is highly preferred.
A minimum of 2+ years of supervisory or shift-lead experience in a cleanroom context is preferred.
Bachelor’s Degree in Biology, Microbiology, Biochemistry, or a closely related technical science discipline is highly preferred.

Responsibilities

Administer and govern the formal aseptic behavior certification and re-certification program for all personnel entering classified spaces, including manufacturing, support, engineering, and cleaning teams.
Serve as the primary, on-the-floor technical coach inside aseptic cleanrooms; conduct regular GEMBA walks to actively observe, reinforce, and fine-tune correct gowning mechanics and behavior.
Monitor Aseptic Process Simulation (APS) media fills and commercial operational runs to proactively identify method optimization areas and adapt technical training packages.
Partner with validation and manufacturing teams to provide direct aseptic technique guidance, oversight, and control during formal smoke studies.
Educate, mentor, and guide manufacturing operators on critical bioburden minimization strategies during standard line clearances, product runs, and complex non-routine cleanroom interventions.
Collaborate across Manufacturing and Quality Assurance to investigate human-factor deviations linked to microbial contaminations, formulate corrective action plans for alert limits, and author robust CAPAs.
Author, design, and update specialized GxP training modules; collaborate with the centralized training department to ensure all qualifications are perfectly tracked in the Learning Management System (LMS).