Operations Gowning Trainer (Biotech)

TL;DR

Operations Gowning Trainer (Biotech): Performing manufacturing gowning training and execution within a cGMP cleanroom environment with an accent on compliance, quality standards, and personnel qualification. Focus on executing instructor-led qualifications, developing gowning processes, and ensuring adherence to Good Documentation Practices.

Location: Onsite in Raritan, New Jersey, United States. Must be able to independently transport themselves between various sites/locations

Salary: $59,168 - $77,658 USD

Company

Global biotechnology company dedicated to treating and curing life-threatening diseases through advanced cell therapies.

What you will do

• Support the Gowning Training Program for clinical and commercial operations in a cGMP cleanroom environment.
• Execute Instructor Led Trainings (ILT), qualifications, and requalifications for CAR-T personnel.
• Perform gowning activities to support cell culturing, purification, aseptic processing, and cryopreservation.
• Aid in the development of manufacturing gowning processes and associated documentation.
• Drive continuous improvement of gowning techniques based on observations and team feedback.
• Maintain accurate records in SOPs and logbooks following Good Documentation Practices (GDP).

Requirements

• HS Diploma with 4-6 years of Biotech/Pharmaceutical experience OR Bachelors degree in Life Sciences or Engineering with 0-2 years of experience.
• Knowledge and ability to operate manufacturing and lab equipment.
• Knowledge of Process Excellence Tools and routine/non-routine sampling methods.
• Physical ability to stand, walk, climb, bend, and lift up to 25 lbs.
• Must be able to perform gowning procedures to work in manufacturing core.

Culture & Benefits

• Medical, dental, and vision insurance.
• 401(k) retirement plan with company match that vests fully on day one.
• 8 weeks of paid parental leave after 3 months of employment.
• Comprehensive PTO policy including vacation, personal, sick time, and 11 company holidays.
• FSA and HSA options, life and AD&D insurance, and disability coverage.
• Commuter benefits, well-being initiatives, and peer-to-peer recognition programs.