Quality Systems Engineer
On-site · Cork, Munster, Ireland
Job Summary
Lab systems life cycle management and validation in the QC Laboratory. Implementing and maintaining computerized systems, coordinating LIMS upgrades, developing and maintaining master data plans, and ensuring data integrity and quality documentation. Lead FMEA and troubleshooting activities, provide support to transfer and validation groups, coordinate LIMs training, and develop LIMs SOPs aligned with global policy. Requires a BSc in analytical chemistry, microbiology, or related discipline and 4+ years in a medical device/pharma environment; experience with LIMS (LabVantage preferred), CSV/validation, and familiarity with TrackWise/Falcon, MES, and SAP is advantageous.
Required Qualifications
- BSc in Analytical Chemistry, Microbiology or related discipline
- A minimum of 4 years practical work experience in a Medical Device/Pharmaceutical environment
- Experience in LIMS – LabVantage an advantage
- Experience in CSV/validation activities
- Experience in LIMS, Trackwise/Falcon, MES and SAP an advantage
- Thorough, practical and persistent self-starter
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