Quality Systems Engineer

Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimaginable with us.

The Role

Reporting to the QC Laboratory Supervisor, the Lab Systems Specialist is a key member of the QC Laboratory team implementing and maintaining computerized systems to QC Laboratories.
The Lab Systems Specialist will work on several different activities including systems implementation, validation, master data and change management.

Duties

•    Lab systems life cycle management – qualification, management, decommissioning, etc.
•    Data integrity risk assessments for lab systems
•    Implementing data integrity improvements as required
•    Validation of laboratory equipment, software, spreadsheets
•    Ensure IT and business global support for the implementation is in place
•    Co-ordinate and execute LIMS upgrades and new releases for the Blarney site
•    Develop and maintain master data plan for Blarney
•    Ensure protocols, reports and quality documentation are drafted and approved prior to use
•    Lead FMEA’s and troubleshooting activities
•    Provide technical support to technical transfer and validation groups
•    Co-ordinate LIMs training
•    Develop and maintain LIMs SOP’s for the site ensuring alignment with the global policy
•    Contribute to Risk Mitigation initiatives such as FMEA and Risk Assessments
•    Other duties as required

Who You Are

•    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 

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology. We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!