CSV engineer

2 weeks ago

Dublin Pike, Ireland QCS Staffing Full time

CSV Engineer - Ireland, Dublin - Long Term Contract

One of the top 10 best companies to work in Ireland is looking for CSV engineer for their large-scale new facility in Dublin. Is this you?
CSV Engineer - Ireland, Dublin - Long Term Contract

One of the top 10 best companies to work in Ireland is looking for CSV 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

Seniority level Seniority level Mid-Senior level
Employment type Employment type Contract
Job function Job function Engineering and Information Technology
Industries Staffing and Recruiting
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