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CSV Engineer at Career Jet - Ireland

cork, Dublin County, Ireland -

Full Time

Start Date

Immediate

Expiry Date

18 Dec, 26

Salary

80000.0

Posted On

19 Sep, 26

Experience

12 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Industry

Pharmaceutical Manufacturing

Description

Execute and support the full computer system validation lifecycle, including planning, testing, implementation, and periodic review activities.
Develop, review, and maintain validation documentation such as Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Summary Reports.
Collaborate with Quality, IT, Engineering, and Operations teams to ensure systems comply with GxP, FDA 21 CFR Part 11, Annex 11, and company quality standards.
Lead validation activities for new system implementations, upgrades, and infrastructure changes across manufacturing, laboratory, and business systems.
Investigate and assess deviations, incidents, and change controls to determine validation impact and ensure continued compliance.
Support internal audits and regulatory inspections by providing validation documentation and subject matter expertise as require

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Responsibilities

Execute and support the full computer system validation lifecycle, including planning, testing, implementation, and periodic review activities.
Develop, review, and maintain validation documentation such as Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Summary Reports.
Collaborate with Quality, IT, Engineering, and Operations teams to ensure systems comply with GxP, FDA 21 CFR Part 11, Annex 11, and company quality standards.
Lead validation activities for new system implementations, upgrades, and infrastructure changes across manufacturing, laboratory, and business systems.
Investigate and assess deviations, incidents, and change controls to determine validation impact and ensure continued compliance.
Support internal audits and regulatory inspections by providing validation documentation and subject matter expertise as require