Specialists in Life Science Automation and IT Systems

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CSQV Specialist 1354

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.
 

CSQV Specialist 1354

SimoTech has an opportunity for a CSQV Specialist with strong Computer Systems Validation (CSV) skills to work within the QA area of a Biologics facility. Those with automation validation 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

  • Quality oversight of processes and procedures related to Data Integrity, Computerised Systems and Automation compliance.
  • Quality oversight for CSV and IT compliance documentation and associated data.
  • Ensure systems and are in line with relevant regulatory and other requirements.
  • Review and approve computerised system validation documentation, including URS, FDS, Test Protocols/Reports, SOPs, and data integrity risk assessments etc.
  • Quality and cGMP input and oversight for all Data Management and Data Integrity activities.
  • Software, equipment, and instrument qualification when required.
  • Event/deviation investigation and change evaluation during qualification, to ensure the systems, software and equipment meet quality and compliance requirements prior to release.
  • Ensure that all manufacturing processes, QC, and enterprise systems perform and operate as per their design.
  • Work with all personnel, 3rd parties, and visitors to ensure that all safety policies, procedures, and regulations are fully adhered to across the site on an ongoing basis.


Qualifications

  • Bachelors or master’s degree in Engineering, Information Systems, Computer Science, or the Life Sciences.
  • 5 years’ experience in a GMP Quality environment, with a minimum of 2 of those years in a technical role.
  • Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
  • Demonstrated knowledge of GxP regulations (e.g., EU-GMP, FDA, ISO), data management and data integrity and Computerised systems validation requirements.
  • Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration.


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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