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Senior CSV Engineer 1304

North Leinster  

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 1304

SimoTech require a Senior CSV Engineer with strong planning and organisational skills The ideal candidate will have 5+ years’ experience working in an Automation environment within a Biologics facility. Those with operational support experience will be at a distinct advantage. This project offers the opportunity to work on a state of the art greenfield Biotechnology site based in North Leinster, Ireland.



Key Responsibilities

  • Support and encourage others in the team, showing flexibility in the delivery of team results.
  • Design, generate and execute test procedures and test protocols, overseeing and reporting findings and non-conformances raised during all types of testing.
  • Engage in business analysis activities.
  • Ensure that computer systems and its associated documentation are fully compliant with site specific policies and regulations, good manufacturing practices and industry regulations.
  • Plan, organise and prioritise own workload while assisting other team members in doing so, to achieve agreed goals and ensure all relevant deadlines are met.
  • Support the preparation of GxP Computerised System Lifecycle documents, including validation plans, requirements specifications, risk assessments, qualification protocols, requirements traceability matrices and validation reports.


Qualifications

  • Bachelors or Master's degree in Engineering, Computer Sciences or related discipline.
  • 5+ years' experience working in the Life Sciences industries.
  • Proficiency in PLC/Automation system validation.
  • Excellent experience with the Microsoft Office suite, with strong technical writing skills.
  • Ability to work well with diverse, multi-disciplined groups.
  • Ability to negotiate/compromise with other team members to achieve project goals.
  • Experience of Good Manufacturing Practices (GMPs), database systems and GxP regulations such as CFR Part 820 and CFR Part 11 is preferred.
  • Excellent technical writing 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.


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