Manufacturing Technician I

2 weeks ago

Fremont, United States Planet Pharma Full time

**Sunday-Wednesday, 2:00pm-12:30pm**

6 Month Contract (May extend or convert to permanent)

$33/hour W2


Duties:

  • Executes fundamental unit operations in 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.
  • 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 tanks, manufacturing equipment as well as 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).


Skills:

  • 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.
  • Low to moderate - strong focus on execution of repeatable tasks with moderate technical complexity. Performing highly proceduralized tasks.
  • Basic interactions Manufacturing Cell Culture, Manufacturing Purification, Manufacturing Compliance, Engineering & Technology, Supply Chain, Quality Assurance, Quality Control
  • Does not require extensive technical knowledge of manufacturing operations.
  • Low impact, repeatable, highly proceduralized.
  • 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.


Education:

  • High school degree, entry level position.
  • Associates/bachelors degree or biotechnology vocational training preferred.
  • Preferable 1 or more years of experience in cGMP regulated industry

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