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Quality Engineer

Your role: The ideal candidate will have engineering or science related background with a solid understanding of cGMP guidelines as they pertain to API pharmaceutical manufacturing, with an emphasis on quality assurance, facility, equipment and process qualification activities.  You will be responsible for managing the technical quality aspects associated with API manufacturing and regulatory requirements for the manufacture of clinical and commercial APIs and other solutions.  Areas of emphasis include but are not limited to process validation and capability assessments, facility alarm management (facility temp. pressure, humidity), periodic review of validated systems, trend analysis of facility and utility control data.

 

Who you are:

  • BS in an Engineering or Science related discipline
  • 2+ years pharmaceutical, laboratory, manufacturing or Quality Engineering related experience
  • Previous experience in Biopharmaceutical manufacturing facility & quality systems.
  • Thorough knowledge of cGMPs and SOPs related to Quality.
  • Good working knowledge of associated industry and regulatory guidance documents; FDA guidelines, ISO standards, ASTM standards, etc.
  • Excellent knowledge/understanding of protocol acceptance criteria and capable of determining appropriate Corrective action/Preventative Action (CAPA).
  • ASQ Certified Quality Engineer, Six Sigma training and Lean Manufacturing training desired

 

Job Requisition ID:  188142
Location:  Arklow
Career Level:  D - Professional (4-9 years)
Working time model:  full-time


Job Segment: CAPA, Lean Six Sigma, Pharmaceutical, QA, Quality, Management, Science

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