Technical Trainer - Large Scale Allogenic Manufacturing

About the role

We are seeking a highly proficient technical authority to join our Cell Therapy Manufacturing organization in Portsmouth, NH, as a Technical Trainer.

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).

Requirements

• 5–8 years of advanced experience within an aseptic manufacturing environment or supporting sterile processing lines is required.
• A minimum of 2+ years of supervisory or shift-lead experience in a cleanroom context is preferred.
• 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.
• Bachelor’s Degree in Biology, Microbiology, Biochemistry, or a closely related technical science discipline is highly preferred.

Qualifications

• Routine capability to undergo cleanroom gowning protocols, stand and walk the classified floor frequently, climb facility stairs/ladders, and occasionally lift up to 50 lbs.

Skills

• Advanced experience in aseptic manufacturing environments.
• Proven background in technical instruction or as a Technical Trainer or OJT instructor.
• Strong regulatory compliance grounding in cGMP, PIC/S, and ISO regulations.
• Ability to simplify complex scientific concepts for trainees.

Benefits

• Compensation programs that recognize high performance.
• Medical, dental, and vision insurance.
• Paid time off (PTO).

Pay

Compensation is commensurate with experience.

Schedule

Monday – Friday (Standard Office Hours / Flexed to support manufacturing runs when needed).

Travel

Minimal travel required (