Job Title
Sr.Functional Analyst (ISG)
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 be required to have excellent communication skills.
Experience
6 - 8 years
Required Skills
Technical Skills: Empower other Lab systems, Labware, any LIMS
CSV Domain Skills
Knowledge of 21CFR Part 11 requirements, ER/ES and data integrity guidelines is desirable
Strong oral and written communication skills; proven ability to communicate and build relationships cross‑functionally
Self‑motivated, detail‑oriented and excellent organizational and time‑management skills
Capability to relate well with others within and outside the laboratory area
Nice to have skills
Domain Skills: Manufacturing and Supply Chain
Technology
Custom Service
Shift
Day
Responsibilities
Manage lab equipment validation projects from software install to business release
Prioritize CSV activities in line with the 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 and liaise with service providers to determine successful installation of instrument software and ensure correct configuration
Determine specific configurations for the software (e.g., how data is saved and named), understand and define user permissions, execute test scripts, analyze test results, and determine acceptability against pre‑determined criteria
Work with the 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 throughout the document body (e.g., headings, font type, font size, paragraph spacing, text alignment, correct tense)
Follow all 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)
Demand Requires Travel?
No
Certifications Required
NA
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