Manufacturing Technician

Responsibilities:

• Excellent employment opportunity for a Manufacturing Technician in the Fremont, CA area.
• Executes fundamental unit operations in Upstream or Downstream manufacturing related to the manufacturing of bulk drug substance in a multi-product facility.
• Performs duties under limited supervision and according to standard operating and manufacturing procedures.
• As an employee, you will actively contribute to the discovery, development and delivery of our products to our patients and customers.
• 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.

Experience:

• Required, High School Diploma or General Education Degree (GED) Preferred, Associates/Bachelor's Degree with (1) year closely related Technical experience, preferably in a Pharmaceutical or Chemicals Manufacturing environment
• 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 and company Fremont 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.
• Schedule: Swing Shift from 1:30PM-12AM, Wednesday to Saturday
  Required Skills: OPERATIONS, CGMPS, MANUFACTURING TECHNICIAN, CIP/SIP, CELL CULTURE
  Additional Skills: PROCESS IMPROVEMENT, CELL COUNTING, SCHEDULING, SIP, PROCESS TESTING, SAMPLING, TEAM LEAD, TRAINING, GMP, FERMENTATION