Manufacturing Technician II - Technical Services
5350 Horton Street, Building CMF Emeryville, CA 12345 US
- Provides Technical Manufacturing Services in a regulated FDA licensed and ISO certified facility, including cross-functional activities associated with production runs in collaboration with all manufacturing groups.
- The role may include special projects such as process development and validation activities where scientific research principles are applied.
- Work as part of a team that supports manufacturing operations on the production floor for buffer/media, glass washers, autoclaves, bioreactors, and various other laboratory equipment with varying levels of automation.
- Executes laboratory operations that include dispensing of chemicals, volumetric and gravimetric measurements, and preparing solutions.
- Operate a variety of laboratory equipment (pH/conductivity meters, Gravimetric Balances, Autoclaves, and Glasswashers))
- Understand basic equipment and procedures required for their areas of responsibility well enough to train other technicians
- Adhere to valid manufacturing procedures and documentation.
- Performs specific glassware preparations per standard operating procedures (cleaning, washing, sterilizing, and distributing within all manufacturing groups.)
- Assists production sustainability through the performance of SAP cycle counting accuracy, reconciliation, reservations, and/or scrapping of expired materials.
- Deliver quality products and services on time to all customers, internal and external.
- Responsible for remaining current on training programs in support of manufacturing processes.
- Abides by the Quality Policy while contributing to organizational goals and metrics
- Documentation: Maintains logbooks, inventory forms, SOPs, equipment, on-the-job training forms, and other records as required.
- Performs legible, clear, and concise data entry into batch records, logbooks, and all other controlled forms used in a cGMP process.
NOTE: For the right candidate the potential for conversion is possible.
- Complies with cGMP and ISO requirements.
- Understands basic procedures required for their responsibilities.
- Maintains accurate documentation in related to manufacturing process.
- Demonstrates leadership skills to train and guide fellow associates.
- Understands concepts involving a variety of lab equipment (pH meters, gravimetric balances, autoclaves, and glasswashers)
- Very good verbal and written communication skill
- Ability to handle multiple tasks simultaneously
- Requires math and computer skills including ability to use a calculator to perform basic statistical functions.
- Understands basic computer applications MS Word, Excel, PowerPoint
- At least 1 year experience with a AA, AS in a GMP environment
- Must have knowledge of reagent/buffer preparation processes
- Experience following and writing SOPs
- Computer knowledge required with experience using MS Word and Excel
- Strong attention to detail able to document work accurately, and excellent organizational skills
- Experience in project management is desirable
- Knowledge in SAP is desirable
- Able to lift and push up to 50 lbs. (with assistance)
Vision Testing required (color, acuity)
At minimum Associate degree or Completion of certified biotech program with a Biotech Certificate of Achievement and/or Biotechnology A.S degree