Computer System Validation (CSV) Engineer
This is a 12-month contract position offering a daily rate of €500. The ideal candidate must have a valid Irish working visa.
Job Summary
We are seeking an experienced Computer System Validation (CSV) Engineer with a strong background in Laboratory Instrument Qualification to join our team at {company}.
Key Responsibilities:
* 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.
Qualifications:
* Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related field.
* 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.