Manufacturing Technician II, Parts Preparation

2 weeks ago


Toledo, Toledo, United States BioSpace, Inc. Full time
Job Summary

We are seeking a highly skilled Manufacturing Technician II to join our team in a biomanufacturing environment. The successful candidate will be responsible for operating equipment, inspecting, cleaning, and sterilizing equipment, assembling/disassembling equipment, performing area cleanings, and completing batch record entries.

Key Responsibilities
  • Operate assigned machinery, including parts washers and autoclaves, to ensure efficient and effective production processes.
  • Inspect and clean equipment to maintain a cGMP environment and ensure product quality.
  • Assemble and disassemble equipment, wrap, operate, and rinse/sanitize various equipment.
  • Perform set-up activities, including cleaning/stocking of areas, spraying items through airlocks, and setting up parts wash and autoclave loads per SOP/Form.
  • Perform cleaning and housekeeping activities for assigned areas to maintain a cGMP environment.
  • Perform visual inspections of equipment for cleanliness, as specified per SOP, and obtain visual inspection training certification.
  • Obtain knowledge to print off SOPs/Forms via ECMS.
  • Perform batch record and GMP documentation entries, maintain records and/or logs, and perform mathematical computations as needed.
Requirements
  • Must have the ability to effectively understand, read, write, communicate, and follow instructions in the English language.
  • Good attention to detail is required, and the individual must be capable of keeping accurate records and performing mathematical calculations.
Preferred Background
  • High school graduate, vocational school graduate, or equivalent.
  • Experience in a pharmaceutical or cGMP regulated environment.
  • Prior production experience.
  • Experience working in a LEAN manufacturing environment.
  • Knowledge of cGMPs and FDA policies/procedures.


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