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The initial focus of this role will be part of the AR30 startup team on Admin Day shift to prepare the facility for Operational Readiness. After the facility startup phase (up to one year), the successful incumbent will be expected to join a shift team working a 12-hour rotating day shift. The shift pattern will be a 7PM 7AM structure with a rotation covering 7 days per week.

Under general supervision, the Manufacturing Process Technician will routinely perform simple to moderately-complex processes according to Standard Operating Procedure and Batch Records. Generally, this will include all aspects associated with bulk manufacturing in aseptic and non-aseptic environments.

Responsibilities:

  • Equipment and parts cleaning using manual and automated methods and equipment
  • Assembly, disassembly, cleaning, and steaming of portable and stationary tanks and associated equipment
  • Operation and process monitoring of clean systems, autoclaves, and processing equipment
  • Sample collection, processing, storage and delivery
  • Product and component reconciliation
  • Solution preparation and transfer
  • Strict adherence to current Good Manufacturing Practices (cGMP's), responsible to accurately complete process-associated documentation, make calculations and perform the physical tasks associated with bulk manufacturing and other duties as assigned.
  • Basic Qualifications:

    Basic Qualifications

    Associates degree and 2 years of Manufacturing or Operations experience

    OR

    2 years in a technical school setting with hands-on experience

    OR

    High school diploma / GED and 4 years of Manufacturing or Operations experience

    Preferred Qualifications:

    Preferred Qualifications
  • 1+ plus years of experience in a GMP/ other regulated environment.
  • Demonstrated knowledge of GMP principles.
  • Filling and Finishing or Packaging manufacturing experience.
  • Ability to stand or sit for extended periods of time
  • Ability to maintain focus during repetitious tasks over the course of a shift.
  • Ability to assemble, disassemble, operate and understand simple to moderately complex equipment per procedures.
  • Basic understanding of measurements, calculations and the metric system
  • Ability to work effectively in an individual and team setting.
  • Ability to document process tasks in electronic batch records.
  • Coachable, ability to take coaching/critique and show learned/measurable improvement.
  • Capacity to follow written procedures, recognize and report malfunctions.
  • Strong communication skills.
  • Ability to perform assignments with a high degree of focus/attention to detail.
  • Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

    Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.


    Associated topics: biochemistry, bioinformatic, biology, biomechanics, bioprocess, genetic, medical, msat, neuro, neuroscience

    * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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