Manufacturing Technician
Job Title- Manufacturing Technician
Duration- 06 Months (possibility of extension)
Location- Fremont, CA 94555
Duties:
- Executes independently with adequate training non-complex fundamental operations as parts cleaning, weigh and dispense, equipment prep, kits assembly, and staging. Performs internal support duties including stocking consumables/materials, updating controlled SOP binders, appropriately discarding expired reagents, recognizing and reporting process and equipment anomalies.
- Executes with oversight of qualified staff fundamental tasks as CIP and SIP of BR's, tanks, manufacturing equipment as well as media or buffer prep and transfer into tanks and bags
- Daily analytics and maintenance of analytical equipment. Cleaning and setup of equipment
- 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).
- Keeps own training on track and trains other technicians and associates on operations.
- Contributes to Quality activities as investigations and area walk-throughs.
Skills:
- Experience working with established GMP procedures and bulk manufacturing is a plus. Technical knowledge of manufacturing systems, methods and procedures.
- Understanding of purification/cell culture processes. Possess effective troubleshooting skills with equipment and/or process.
- Preferable 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.
- Ability to read and understand SOPs and work instructions and document work in a written format applying cGMP standards.
- Ability to work as part of a high performing team and collaborate effectively with staff.
- Working in a highly regulated environment following all applicable SOPs, OCPs and BGSs for cGMP, EHS and Compliance policies.
- Required to work according to given schedules in a 24/7 shift structure and flexibility to adapt working schedule upon prior given notice.
Education:
Preferred, associates degree with (1) year closely related technical experience, preferably in a pharmaceutical or chemicals manufacturing environment.
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