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Automation CSV Engineer 1367

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.
 

Automation CSV Engineer 1367

SimoTech has an opportunity for a Computer Systems Validation Engineer with automation project experience to join our team. The successful candidate will gain experience on key capital projects for a continuous manufacturing facility onsite a global pharmaceutical client of ours based in Cork.



Key Responsibilities

  • Manage and coordinate the Automation CSV deliverables for new and existing projects from initiation to release. Prioritising support activities in line with project schedules.
  • Liaise with service providers and team members to determine successful installation of software and ensure correct configuration.
  • Generate validation documentation in accordance with site procedures and regulatory guidelines, including but not limited to 21 CFR Part 11, EU GMP Annex 11, and Data Integrity Guidance.
  • Follow all relevant Environmental, Health and Safety procedures and assist in incident investigations as required.
  • Recognise the importance of the quality control function in pharmaceutical production.
  • Initiate and implement Change Control activities in accordance with Quality Standards and Practices.
  • Participate, contribute to, and report at team meetings.


Qualifications

  • Minimum 5 years’ experience implementing IT solutions, systems integration, support & validating IT applications and interfaces.
  • Experience of CSV on automation projects.
  • Experience of writing validation plans, requirements gathering, design documentation, system configuration, system testing and troubleshooting.
  • Knowledge of GAMP, 21 CFR Part 11 etc. and data integrity guidelines.
  • Basic knowledge or exposure to DeltaV.
  • Knowledge of Kneat validation software solutions is beneficial.


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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