My client, a leading global Biologics organisation is looking for an experienced QC Lab Systems professional to support an ongoing project at their new Leinster site. This is the organisation's first investment in Europe, with the site being designed to run continuous bioprocessing. This large-scale global expansion is in response to growing customer demand across both development and manufacturing needs.
This will be an opportunity to gain experience and exposure within a start-up Biologics greenfield facility.
This position forms a key part of the site CSV/CQV project team, and will you will be responsible for a number of important tasks including but not limited to:
- Draft test cases for QC laboratory computerized system.
- Be responsible for establishing and revising of VP for QC laboratory computerized system.
- Lead risk assessment before test execution, such risk assessment includes but not limited to ERES assessment, system functional risk assessment.
- Responsible for review of the vendor validation documents, such as validation protocols and validation summary reports.
- Participate in deviation investigation, analysis and change assessment.
- Minimum of a BSc in an Engineering or Science related discipline.
- 3+ years' experience working in similar projects within a highly regulated GMP manufacturing operation in Pharma or Bio.
- A strong portfolio of Lab Systemes and Equipment Validation work is required and proven skill in this area.
- Excellent communication, problem-solving, and organization skills, attentive, careful and meticulous, with strong team-work ability.
High-value hourly rate offered
To discover more about this opportunity, apply now or contact Helena Boyle at HRM on +353 1 6321870 or 0873360953 for a confidential discussion.