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Quality Engineer - Equipment and Commissioning

Newark Metro Area, NJ

Posted: 08/02/2019 Job Type: Scientific Job Number: JN -082019-25327
BS Engineering or scientific discipline with 2 - 5 years of experience including:
  • Advanced knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
  • Advanced knowledge of pharmaceutical, manufacturing and laboratory systems and equipment.
  • Execute the historical performance review (HPR), a bi annual review of equipment performance and use.
  • Compile data gathered from HPR and use to analyze trends that could show equipment failure or out of trend.
  • Review equipment logbooks, procedures and use for adherence to local, global and regulatory policies, procedures and guidelines.
  • Identify and recommend actions to take as a result of the completed HPR.
  • Perform gap analysis on existing equipment and technologies to ensure compliance.
  • Review new equipment and technologies as it comes to site to ensure compliance.
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