Manufacturing Technician - TCS

La Jolla, CA

Job ID: 501

Job Req code: 501

Category: Production

Job Type: Manufacturing

The Manufacturing Technician I - TCS is responsible for completing and assisting with daily tasks associated with support related functions for TC including assembly and sterilization of sub-assembly items, material management and manufacturing final product for commercial distribution. Responsible for following SOPs, performing daily tasks in a clean room/cGMP environment per the current QSRs. May also be responsible for troubleshooting manufacturing product challenges. Follows established company rules, regulations and safety precautions, and maintains quality standards

 

70% of time:

  • Perform responsibilities that include various duties that are required to produce cell based product. Some of these duties include: assembly and sterilization of sub-assembly items, material management which consists of timely transfer and replenishment of materials and/or supplies to point-of-use location, inventory accuracy and process kitting. In order to perform these duties, the MFG Technician I-TC must be familiar with documentation for each task, cleaning procedures, aseptic processing techniques, Good Manufacturing Practices (GMP) and clean room safety practices and procedures.
  • Perform various responsibilities that are required to package a tissue. Some of these duties include: Proper set up and use of many custom built pieces of equipment, Stringent awareness and control of final product and labeling, freezing and accounting of product, transfer of final product into final storage freezers. In order to perform these duties, the Technician I-TC must be familiar with documentation for each task, cleaning procedures, aseptic processing techniques, Good Manufacturing Practices (GMP) and clean room safety practices and procedures.
  • Use and attendance to specialized equipment for the creation of materials used in a cellular based manufacturing process.
  • Assembly of Sub-components with other Sub-components to set up systems for further manufacturing of materials used for a cellular product.
  • Assists in execution of area cycle counts.
  • Assists in providing positive and constructive individual feedback and building teamwork. Follows high standards of quality and teamwork that are set forth by the area Supervisor or Lead. Gains understanding of continuous process improvement methodologies that are endorsed by senior management and direct supervisor.
  • Assists multiple departments including DG Growth, Cell Expansion, Solutions Prep, Support Services, and Research groups for daily needs and special requests.
  • Will participate in weekly area walkthrough to assess overall condition of MFG area.
  • Demonstrate competence in basic computer skills including; Outlook, Excel, and Word.
  • Demonstrate competence and awareness of company IT interactions.
  • Assure that you are always currently trained in all aspects of your specified training matrix
  • Under direct guidance, train on and perform responsibilities that are required to produce solutions for processing.
  • Capable of performing certain production related responsibilities; batch record completion, assist in ordering needed supplies and documents, assist in ensuring areas is properly stocked with needed supplies to perform all processes, learn how to perform accurate cycle counts.

30% of time:

  • Performs production related tasks as assigned by the Area Supervisor or Group Lead. These tasks can include, but are not limited to, Quality Event Notifications, Facilities Maintenance Requests, ordering supplies and/or equipment for Production, and collaborating with supporting teams to meet company goals.

Requirements

  • Requires a minimum of 1 year prior working experience in a manufacturing environment (Biotech/Pharmaceutical industry) with a high school diploma; 0-1 year with a Biotech Program certificate from an accredited college.
  • Must have hands-on-experience with commonly used production concepts, and practices.
  • General knowledge of clean room practices and familiarity with Current Good Manufacturing Practices (cGMP).
  • Ability to perform calculations using weight measurement, volume, and distance governed by Quality documents and Standard Operating Procedures.
  • Ability to apply common sense understanding to carry out detailed written and oral instructions. Must be detail-oriented with an ability to set priorities, and organize daily work requirements.
  • The Manufacturing Technician I-TC must be able to work as a team member and independently as required.
  • Very strong Mechanical aptitude and demonstrated awareness of process flow and impact.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Working in a clean room environment required. Must clothe in clean room gowns to perform duties. Must be able to push 150+ lbs (on wheels), and lift 50lbs. Effective communication and listening skills are required. Must work with living human cells and various chemicals. Due to the nature of production work, overtime and weekend work is a requirement of employment and is variable based on company needs. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.