CSV Engineer

4 weeks ago

Dublin, Dublin City, Ireland Quanta Consultancy Services Ltd Full time
CSVEngineer - Ireland, Dublin - Long Term Contract

One of the top 10 best companies to work in Ireland is looking forCSV engineer for their large-scale new facility in Dublin. Is this you?

An exciting project there is lots of opportunity to learn new technology and develop current skills within a fast paced €1 billion project. This fantastic client offers the opportunity to work within a large-scale environment with cutting edge technology.

Responsibilities include:
  • Develop and execute validation plans, protocols (IQ/OQ/PQ), and reports for laboratory instruments and computer systems.
  • Perform risk assessments and impact analyses to determine the validation requirements for new and existing systems.
  • Ensure compliance with regulatory requirements (e.g., FDA, EMA, GxP) and industry standards (e.g., GAMP 5).
  • Collaborate with cross-functional teams, including Quality Assurance, IT, and Laboratory Operations, to ensure successful validation and qualification activities.
  • Maintain and update validation documentation, including validation master plans, standard operating procedures (SOPs), and validation summary reports.
  • Conduct periodic reviews and requalification of laboratory instruments and computer systems to ensure continued compliance.
  • Provide training and support to laboratory personnel on validation and qualification processes.
  • Investigate and resolve validation-related issues and deviations.
  • Stay current with industry trends and regulatory changes to ensure ongoing compliance and continuous improvement.
Key requirements include:
  • Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related field.
  • Extensive experience in computer system validation and laboratory instrument qualification.
  • Strong knowledge of regulatory requirements (e.g., FDA 21 CFR Part 11, EU Annex 11) and industry standards (e.g., GAMP 5).
  • Experience with validation of laboratory instruments such as plate readers, liquid handlers, spectrophotometers, and other analytical equipment.
  • Excellent documentation and technical writing skills.
  • Strong analytical and problem-solving abilities.
  • Ability to work independently and as part of a team.
  • Excellent communication and interpersonal skills.
If this role is of interest, please apply now
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