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    Manufacturing Technician - Fremont, United States - Planet Pharma

    Planet Pharma
    Planet Pharma Fremont, United States

    3 weeks ago

    Default job background
    Pharmaceutical / Bio-tech
    Description

    Job Description:

    • 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.

    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
    • 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.
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