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IT CSV Engineer 1325

Cork  

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.
 

IT CSV Engineer 1325

SimoTech requires a CSV Engineer with 5 years’ experience who will be responsible for the validation of IT solutions being implemented for a continuous manufacturing facility for a Pharmaceutical client of ours based in Cork. This Engineer will provide IT systems validation and compliance expertise for newly introduced IT and digital solutions.



Key Responsibilities

  • Manage the CSV aspect of IT projects from software install to business release.
  • Liaise with service providers and IT team to determine successful installation of software and ensure correct configuration.
  • Responsibility for server installations and system related activities e.g. security, admin config settings, access permissions.
  • Generate CSV documentation in accordance with site procedures and GMP guidelines.
  • Execute test scripts, analyze test results and determine the acceptability of results against pre-determined criteria.
  • Work with the business to identify and implement procedural controls to mitigate issues found during testing.
  • Initiate and implement Change Control activities in accordance with Quality Standards and Practices.
  • Determine solutions or recommendations for changes and/or improvements.
  • Prioritize validation activities in line with the project schedule.
  • Collaborating with global IT and Quality teams.
  • Following all relevant Environmental, Health and Safety procedures and assist in incident investigations as required.


Qualifications

  • Minimum 5 years’ experience implementing IT solutions, systems integration, support & validating IT applications and interfaces.
  • Experience of writing validation plans, requirements gathering, design documentation, system configuration, system testing and troubleshooting.
  • Knowledge of 21CFR Part 11 requirements, ER/ES and data integrity guidelines.
  • Experience of MES solutions and OSI PI is an advantage.
  • Experience of data analytics and reporting solutions is an advantage.
  • Experience of server and workstation platforms and working in a Win 10 environment.


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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