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Senior Automation CSV Engineer 1472

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.
 

Senior Automation CSV Engineer 1472

SimoTech has an opportunity for a Senior Automation Computer Systems Validation Engineer to join our team, supporting our client in a state-of-the-art biotechnology site in Cork. The successful candidate will have 5+ years’ experience in a similar role and will support continuous automation projects.



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 ensure successful installation of software and correct configuration.
  • Preparation of test protocols and reports for automation projects on systems including DeltaV and Siemens PLC.
  • Overseeing and supporting software testing activities.
  • 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.
  • Carry out project risk assessments.
  • Assist is project planning and requirements definition.
  • Follow all relevant environmental, health and safety procedures and assist in incident investigations as required.
  • Initiate and implement change control activities in accordance with quality standards and practices.
  • Participate, contribute to, and report at team meetings.


Qualifications

  • Minimum of 5 years’ experience of CSV on automation projects in particular DeltaV systems.
  • Experience of writing validation plans, protocols and reports.Also, requirements gathering, design review and CSV risk assessments.
  • Knowledge of GAMP, 21 CFR Part 11 etc. and data integrity guidelines.
  • Knowledge or exposure to DeltaV.
  • Knowledge of Biopharma equipment and processes.
  • 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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