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Senior CSV Engineer 1303

Dublin  

About SimoTech

SimoTech provides manufacturing automation and IT systems engineering, project management and validation services. We partner with life sciences companies to design, build, operate and optimise critical process automation systems that deliver fast track project delivery, operational efficiency, improve manufacturing agility and achieve regulatory compliance.
 

Why SimoTech

What is it like to work at SimoTech? With a strong collaborative teamwork culture based on respect, trust and excellence, we play a critical partnering role to our clients’ life-changing supply of products to patients. In return, there is excellent salary, career progression, educational support and much more.
 

Senior CSV Engineer 1303

SimoTech currently requires a Senior CSV Engineer for a pharmaceutical project with a client of ours based in Dublin. Candidates must have at least 5+ years’ technical experience of working in a busy manufacturing environment, preferably pharmaceuticals.



Key Responsibilities

  • Support department activities, including but not limited to the preparation of Validation/Qualification plans and strategies, risk assessments, URS, SOPs and Change Controls.
  • Ensure that the computerised systems are in full compliance with both regulatory requirements and with company policies and procedures.
  • Support the resolution of deviations and/or errors and provide quality guidance on GxP regulatory requirements.


Qualifications

  • 3rd level Science / Engineering degree required.
  • Minimum of 5 years relevant CSV experience in either the Biotech or Pharma industry.
  • Thorough knowledge of cGMP regulations related to CSV, including 21 CFR Part 11 and EU GMP Annex 11 is required.
  • Strong knowledge of computerised system development life cycle.
  • Experience of coordination of quality documentation and qualification/validation documentation.
  • Strong technical writing and communication skills.


What SimoTech Can Offer

  • Role provides a high degree of autonomy to allow the successful candidate to reach their full potential.
  • Develop new skills and enhance technical ability by working with innovative technologies in a multi-disciplined environment.
  • Opportunity to work with large corporate clients on exciting capital projects.


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