|Reference # :||19-06410||Title :||Manufacturing Associate I|
|Location :||Fremont, CA|
|Position Type :||Contract|
|Experience Level :||Start Date / End Date :||06/18/2019 / 06/23/2020|
Wed-Sat 6am-430pm. Will train 8-5pm M-F for the first 4 weeks.
Executes, with oversight of qualified staff, complex unit operations including but not limited to batching and inoculation of
bioreactors, operation of bioreactors, process monitoring, and harvest operations.
- Executes independently with adequate training fundamental operations:
- CIP/SIP of bioreactors, tanks, and harvest equipment.
- Media preparation and transfer into tanks and disposables.
- Cell inoculation and transfer.
- Daily analytics and maintenance of analytical equipment.
- May be required to support parts cleaning and weigh and dispense operations.
- Performs internal support duties including stocking consumables/materials, updating controlled SOP binders,
appropriately discarding expired reagents, recognizing and reporting process and equipment anomalies.
- Documents work according to cGMP and cGDP.
- Adheres to established regulations and follows cGMP established by site.
Reports abnormalities and deviations in a timely and accurate manner.
- Adheres to safety standards and identifies unsafe situations / habits and escalates appropriately.
- Maintains production areas according to predefined standards (5s).
- Maintains own training within compliance and trains other technicians and associates on operations upon completion of
- Contributes to Quality activities as investigations and area walk-throughs.
One (1) or more years of experience in cGMP regulated industry.
- Ability to concentrate on detail oriented work in a complex technical setup with a Quality and Right the first time mindset.
- Strong written and verbal communication skills.
- Ability to work with computer-based systems and ideally experience with process control systems (e.g. Delta V) and
manufacturing execution systems (MES).
- Ability to read and understand SOPs and work instructions and document work in a written format applying cGMP
High school degree plus minimum one (1) year work experience in GMP regulated industry
- Associates/Bachelor's degree from an accredited institution or biotechnology vocational training preferred.