Operations Gowning Trainer

Operations Gowning Trainer I – Raritan Training Team (Raritan, NJ)

Role Overview

This position is responsible for performing manufacturing gowning training and the execution of gowning training tasks within a CGMP environment. The trainer ensures quality and maintains the highest standards of compliance with company policies, procedures, and all applicable regulations.

• Support the Gowning Training Program responsible for clinical and commercial operations in a cGMP cleanroom environment.
• Execute Instructor Led Trainings (ILT), qualifications, and requalification of Raritan CAR‑T personnel.
• Conduct manufacturing gowning activities to support cell culturing, purification, aseptic processing, and cryopreservation using appropriate techniques.
• Perform gowning training and execution that follows SOPs and batch records, and record production data according to Good Documentation Practices (GDP).
• Complete tasks on time in compliance with quality systems, cGMP, and LMS requirements.
• Work collaboratively in a cross‑functional team to complete production tasks required by shift schedule.
• Assist in developing manufacturing gowning processes and documentation.
• Drive continuous improvement of gowning techniques and processes, leveraging observations and team input.
• Support schedule adjustments to meet production and business needs.
• Maintain accurate documentation in SOPs, logbooks, GMP documents, and training events.
• Demonstrate training progression through assigned curriculum.
• Maintain a working knowledge of basic cGMP requirements to ensure adherence to compliance policies and regulations.
• Wear appropriate PPE in manufacturing and hazardous working environments.
• Proactively maintain a clean and safe work environment, eliminating safety hazards and communicating observed unsafe behaviors.
• Ensure materials are available for qualifications and training.
• Support the ongoing production schedule by:
  • Arriving on time and following shift schedule.
  • Performing other duties as assigned.
  • Attending departmental and other scheduled meetings.
  • Practicing good interpersonal and communication skills.
  • Demonstrating a positive team‑oriented approach in daily procedures.
  • Promoting and working within a team environment.
  • Learning new skills, procedures, and processes as assigned by management and continuing to develop professionally.
  • Supporting investigation efforts as required.
  • Participating in audit preparation and execution.

• HS Diploma required with 4–6 years biotech/pharmaceutical experience OR equivalent industry experience; or Bachelors degree required in Life Sciences or Engineering with 0–2 years biotech/pharmaceutical experience or equivalent industry experience.
• Interpret and follow a variety of instructions furnished in written, oral, diagram, or schedule form.
• Apply problem‑solving skills in situations with limited standardization.
• Perform basic arithmetic operations in all units of measure (whole numbers, common fractions, and decimals).
• Operate manufacturing, manufacturing‑support, and lab equipment.
• Use Process Excellence Tools.
• Possess solid knowledge of routine and non‑routine testing and sampling methods, techniques, and related equipment.
• Be mobile and able to transport independently between sites/locations as required.
• Communicate with coworkers frequently.
• Stand, walk, climb, bend, and reach with hands and arms as needed.
• Lift up to 25 lbs.
• Perform gowning procedures for work in the manufacturing core.

Medical, dental, and vision insurance; 401(k) retirement plan with company match that vests fully on day one; eight weeks of paid parental leave after three months; paid time off including vacation, personal, sick, floating holidays, and eleven company…