Quality Engineer

Posted 12 Feb 2019

Arklow, Leinster - Ireland

Req Id 188142

Details

A career is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. 
 


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

 



What we offer: With us, there are always opportunities to break new ground. We empower you to fulfill your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at

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