Manufacturing Technician

Job Details

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.

 Spectraforce Technologies

 05/02/2024

 Fremont,CA