Operations Gowning Trainer
Legend Biotech
June 24, 2026
On-site
Raritan, NJ
Operations
Operations Gowning Trainer I (Raritan Training) — Raritan, NJ
Role Overview
Perform manufacturing gowning training and execution in a cGMP environment, ensuring quality and compliance with company policies, procedures, and applicable regulations.
Key Responsibilities
- Support the Gowning Training Program for clinical/commercial cGMP cleanrooms.
- Execute Instructor Led Trainings (ILT), Qualifications, and Requalification for Raritan CAR-T personnel.
- Perform gowning for cell culturing, purification, aseptic processing, and cryopreservation using appropriate techniques.
- Execute and document gowning training per SOPs/batch records using GDP; maintain on-time completion and LMS requirements.
- Support cross-functional shift production activities; aid development of gowning processes/documentation.
- Drive continuous improvement of gowning techniques; support schedule adjustments.
- Complete documentation (SOPs, logbooks, GMP documents, training events); demonstrate training progression.
- Maintain working knowledge of basic cGMP; use proper PPE; maintain clean/safe work environment.
- Ensure materials are available for qualifications/training; support investigations, audits, and meetings.
Requirements
- HS Diploma (4–6 years biotech/pharma) or BS in Life Sciences/Engineering (0–2 years biotech/pharma).
- Ability to interpret instructions (written/oral/diagram/schedule) and follow them.
- Solve practical problems with limited standardization.
- Basic math (add/subtract/multiply/divide), units/decimals.
- Operate manufacturing/manufacturing-support/lab equipment; knowledge of Process Excellence Tools.
- Knowledge of testing/sampling methods and related equipment.
- Mobile; communicate frequently; lift 25 lbs; stand/walk/climb/bend/reach.
- Ability to perform gowning procedures for manufacturing core.
Benefits (for permanent full-time employees): medical/dental/vision; 401(k) with match; 8 weeks paid parental leave after 3 months; paid time off (vacation/personal/sick/floating holidays + 11 holidays); plus voluntary benefits (e.g., FSA/HSA, life/AD&D, disability, supplemental insurance).
Role Overview
Perform manufacturing gowning training and execution in a cGMP environment, ensuring quality and compliance with company policies, procedures, and applicable regulations.
Key Responsibilities
- Support the Gowning Training Program for clinical/commercial cGMP cleanrooms.
- Execute Instructor Led Trainings (ILT), Qualifications, and Requalification for Raritan CAR-T personnel.
- Perform gowning for cell culturing, purification, aseptic processing, and cryopreservation using appropriate techniques.
- Execute and document gowning training per SOPs/batch records using GDP; maintain on-time completion and LMS requirements.
- Support cross-functional shift production activities; aid development of gowning processes/documentation.
- Drive continuous improvement of gowning techniques; support schedule adjustments.
- Complete documentation (SOPs, logbooks, GMP documents, training events); demonstrate training progression.
- Maintain working knowledge of basic cGMP; use proper PPE; maintain clean/safe work environment.
- Ensure materials are available for qualifications/training; support investigations, audits, and meetings.
Requirements
- HS Diploma (4–6 years biotech/pharma) or BS in Life Sciences/Engineering (0–2 years biotech/pharma).
- Ability to interpret instructions (written/oral/diagram/schedule) and follow them.
- Solve practical problems with limited standardization.
- Basic math (add/subtract/multiply/divide), units/decimals.
- Operate manufacturing/manufacturing-support/lab equipment; knowledge of Process Excellence Tools.
- Knowledge of testing/sampling methods and related equipment.
- Mobile; communicate frequently; lift 25 lbs; stand/walk/climb/bend/reach.
- Ability to perform gowning procedures for manufacturing core.
Benefits (for permanent full-time employees): medical/dental/vision; 401(k) with match; 8 weeks paid parental leave after 3 months; paid time off (vacation/personal/sick/floating holidays + 11 holidays); plus voluntary benefits (e.g., FSA/HSA, life/AD&D, disability, supplemental insurance).