• Vacaville, CA
    3 days ago

    Job Description

    Responsible for producing innovative bio-therapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment; maintaining areas in high state of inspection preparedness and utilizing business systems for inventory and process management. Maintain records to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP). Participate in the routine production of mammalian cell culture products within the Vacaville Manufacturing Facility, operating in at least one of the following production areas:

    • Minimum Requirement: High School Diploma or GED.
    • We Welcome Diverse Backgrounds: This is an excellent opportunity for:
    • Motivated individuals with a mechanical background/hands-on experience looking to transition into a new industry.
    • Current college students (Junior, Technical, or Community College) looking for a stable night shift.

    Preferred Qualification:

    • Some advanced college-level coursework or a technical degree/certification is highly preferred.
    • Upstream Manufacturing (UM): Primary focus is the cleaning, sterilization and operation of fixed vessel systems for media preparation, fermentation, and harvest operations; perform seed train operations; perform dispensing of components; handle and aliquot hazardous materials.
    • Downstream Manufacturing (DM): Responsibilities include the operation and cleaning of fixed tank systems, the operation and cleaning of filtration systems, large-scale buffer preparation, and the operation of column chromatography systems; perform dispensing of components; handle and aliquot hazardous materials. Follow established safety and environmental guidelines and procedures for all work performed. Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions.
    • Fosters safe work practices:Operate systems that clean and sterilize tanks and filtration systems.
    • Prepare materials for the production process.
    • Exhibit detail-oriented documentation skills to ensure Right-First-Time operations (e.g. tickets, labels, equipment reading).
    • Escalate process issues as necessary to ensure resolution of issue.
    • Comply with cGMP, SOP and manufacturing documentation.
    • Use automation to perform production and equipment operations.
    • Provide support to Manufacturing to meet production demands.
    • Assemble and prepare equipment for production.
    • Communicate effectively and professionally in a team environment.

    Numbers & Facts

    LocationVacaville, CA

    Skills

    • Automationunmatched
    • Business Solutionsunmatched
    • Cell Culturesunmatched
    • Chromatographic Systemsunmatched
    • Column Chromatographyunmatched
    • Communication Skillsunmatched
    • Current Good Manufacturing Practice (cGMP)unmatched
    • Detail Orientedunmatched
    • Diversityunmatched
    • Documentationunmatched
    • Hazardous Materials/Substancesunmatched
    • High School Diplomaunmatched
    • Higher Educationunmatched
    • Inventory Managementunmatched
    • Large-Scale Systemsunmatched
    • Manufacturingunmatched
    • Medicineunmatched
    • Problem Solving Skillsunmatched
    • Process Managementunmatched
    • Production Controlunmatched
    • Production Systemsunmatched
    • Record Keepingunmatched
    • Regulatory Requirementsunmatched
    • Safety/Work Safetyunmatched
    • Standard Operating Procedures (SOP)unmatched
    • Sterilizationunmatched
    • System Operationsunmatched

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