About The Position

Performs functions associated with cGMP manufacturing operations within a biologics production facility. The role includes working with engineers on setup and calibration, performing rework and quality testing related to production of parts, components, and final materials, and using systems such as LIMS, SAP, and automated control systems to collect and evaluate operating data. That data may be used to make on-line adjustments to products, instruments, or equipment. The technician determines and may help develop methods and procedures to control or modify the manufacturing process. The position works on assignments that are semi-routine in nature, follows established procedures for routine work, and requires instructions mainly for new assignments. It applies acquired job skills and company policies and procedures to complete assigned tasks, while recognizing when occasional deviations from accepted practice may be needed.

Requirements

  • Associate degree in science or equivalent experience, with 2 or more years of relevant experience; alternatively, a bachelor's degree with 1 or more years of relevant experience; or a bachelor's degree in engineering with no years of experience required.
  • Apply acquired job skills and company policies and procedures to complete assigned tasks.
  • Recognize the need for occasional deviation from accepted practice when working on semi-routine assignments.
  • Follow established procedures for routine work and require instructions mainly for new assignments.

Responsibilities

  • Ship finished materials.
  • Maintain inventory levels.
  • Sample in-process and raw materials.
  • Run the glass washer and autoclave.
  • Prepare buffers and media.
  • Prepare equipment using CIP/SIP.
  • Perform cell culture activities from vial thaw through production scale.
  • Perform column chromatography.
  • Perform tangential flow filtration.
  • Work with engineers on equipment setup and calibration.
  • Perform rework and quality testing related to the production of parts, components, and final materials.
  • Collect and evaluate operating data using systems such as LIMS, SAP, and automated control systems, and use it to make on-line adjustments to products, instruments, or equipment.
  • Determine and may assist in developing methods and procedures to control or modify the manufacturing process.

Benefits

  • Paid time off, including vacation, holidays, and sick time.
  • Medical, dental, and vision insurance.
  • 401(k).
  • Eligibility to participate in short-term incentive programs.
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