Job TitleSr.Functional Analyst (ISG)Job SummaryThe 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/iExperience6 - 8 yearsRequired SkillsTechnical Skills: Empower other Lab systems Labware any LIMS CSV Domain Skills:Nice to have skillsDomain Skills: Manufacturing and Supply ChainTechnologyCustom ServiceShiftDayResponsibilitiesMinimum 3 years experience supporting and validating lab equipment updating documentation system testing troubleshootingExperience of analyzing and challenging s/w to identify gaps.Knowledge of 21CFR Part 11 requirements ER/ES and data integrity guidelines is desirableStrong oral and written communication skills are required with proven ability to communicate and build relationships cross-functionallySelf-motivated detail-oriented and excellent organizational and time management skillsCapable of relating well to other people with whom s/he comes in contact both within and outside of the laboratory areaManage lab equipment validation projects from software install to business releasePrioritize CSV activities in line with the project schedule and monitor budgetsGenerate computer system validation documentation e.g. Design Spec Configuration Spec Testing Security Plan Test Summary Report in accordance with site procedures and GMP guidelinesReview of software release notesLiaise with service providers to determine successful installation of instrument software and ensure correct configurationDetermine any specific configurations for the software e.g. how data is saved and namedUnderstand and define user permissionsExecute test scripts analyse test results and determine the acceptability of results against pre-determined criteriaWork with the business to identify and implement procedural controls to mitigate issues found during testingInitiate and implement Change Control activities in accordance with Quality Standards and PracticesDetermine solutions or recommendations for changes and/or improvementsProduce documentation that is well written and consistent throughout the document body e.g. headings font type font size paragraph spacing text alignment correct tenseFollow all relevant Environmental Health and Safety procedures and assist in incident investigations as requiredJob LocationPrimary Location :IECRCORC01(ITIRL Cork - CR IRL CLT/RMT)Alternate Location :NA NAAlternate Location 1 :NA NAJob TypeSr.Functional Analyst (ISG) (60SG00)Demand Requires Travel?NoCertifications RequiredNA
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