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Project Engineer (Clean, Packaging & NPI)

Engineering
Cork
Abeer Ansari
Permanent
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Job Reference: JO-2007-65307_1595336174

Summary:

Job Purpose:


The selected candidate will be responsible for the clean and pack process for multiple projects with the support of existing experience clean & pack engineers in the NPI department. He/She will develop, qualify & launch the Clean & Pack process as part of the Core Team.



Key Responsibilities:



  • Process development including PFMEA

  • Process Characterisation through engineering studies

  • Process Qualification/Validation

  • Planning & execution of key deliverables & action plans with the help of the Project Manager

  • Regular reporting on the status, performance, and risks of your project

  • Participate in DFM reviews with Design Team to minimize lifecycle cost

  • Minimize Environmental and Health & Safety effects of your work

  • Adhere to the company's procedures as detailed in the SOP manual

  • Support Regulatory Affairs with product submissions

  • All other duties as directed by direct manager



Requirements:


The ideal candidate would be a planned and organised individual with strong technical or process knowledge/experience in cleaning & packaging within a regulated industry. A strong team player that will own the delivery of elements within their process/technology area. You will need strong interpersonal skills, be able to collaborate effectively to resolve technical challenges. Knowledge/experience in sterility assurance is an advantage.




  • Third level degree in Engineering or similar discipline.

  • 1-3 years' experience in equipment installations/facilities/commissioning

  • Self-motivated, with a focus on H&S, Quality, Delivery, and Cost.

  • Proven Root Cause analysis and problem-solving techniques


Desirable:



  • 1-3 years' experience in equipment operation/installation/qualification in a regulated environment.

  • Exposure to Project Management methodologies

  • Knowledge of medical device or pharmaceutical industries



Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.


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