Job Summary
The Lab Computer System Validation Engineer will be responsible for the validation of Lab Systems in QCL Labs and Manufacturing Operations. We are seeking an enthusiastic and experienced Lab CSV Engineer to join our team. The Lab CSV Engineer will provide systems validation and compliance expertise for newly purchased instruments and support of existing instruments. The position will work within a collaborative Computerised Instruments team and will require excellent communication skills.
Experience
6 - 8 years
Required Skills
Technical Skills: Empower other Lab systems, Labware, LIMS CSV Domain Skills
Nice to Have Skills
Domain Skills: Manufacturing and Supply Chain
Responsibilities
Minimum 3 years experience supporting and validating lab equipment, updating documentation, system testing, troubleshooting.
Experience analyzing and challenging software to identify gaps.
Knowledge of 21 CFR Part 11 requirements, ER/ES, and data integrity guidelines.
Strong oral and written communication skills; ability to build cross‑functional relationships.
Self‑motivated, detail‑oriented, organizational and time management skills.
Relate well to colleagues within and outside of laboratory area.
Manage lab equipment validation projects from software installation to business release.
Prioritize CSV activities in line with project schedule and monitor budgets.
Generate computer system validation documentation (Design Spec, Configuration Spec, Testing, Security Plan, Test Summary Report) in accordance with site procedures and GMP guidelines.
Review software release notes.
Liaise with service providers to determine successful installation of instrument software and ensure correct configuration.
Determine specific software configurations (how data is saved and named) and define user permissions.
Execute test scripts, analyze test results, determine acceptability against criteria.
Work with business to identify and implement procedural controls to mitigate issues found during testing.
Initiate and implement Change Control activities in accordance with Quality Standards and Practices.
Determine solutions or recommendations for changes and/or improvements.
Produce documentation that is well written and consistent (headings, font type, font size, paragraph spacing, alignment, tense).
Follow relevant Environmental Health and Safety procedures and assist in incident investigations as required.
Job Location
Primary Location: IECRCORC01(ITIRL Cork - CR IRL CLT/RMT)
Job Type
Sr. Functional Analyst (ISG) (60SG00)
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