MES Software Quality Engineer

Location: Cork, Ireland

Job Type: Contract

Rate: €Open

You will join a global IT consultancy working with a blue chip pharma. Specialist experience in medical lab equipment systems and software required.

Responsibilities:

• Validate life science business and IT initiatives, including solution validation processes for planning, development, implementation, and testing.
• Collaborate with cross-functional teams to execute validation deliverables.
• Expertise in QC testing, laboratory processes, and experience within a pharmaceutical GMP compliant analytical lab.
• Design, develop, and execute quality deliverables such as Validation Protocols, CSV Regulatory Risk Assessment, etc.
• Strong analytical skills and understanding of MES concepts, functionalities, and system integration principles.
• Conduct testing, troubleshooting, and ongoing maintenance of MES to ensure system reliability and accuracy of data.
• Familiarity with MES software platforms, such as Werum PAS-X, LabX or similar systems.

Requirements:

• Bachelor's degree in fields associated to labs and quality control systems.
• Knowledge of Quality & Lab Manufacturing (GMP) business process for biotech or pharmaceutical industry.
• Specific expertise with Document and Change control process.
• Familiarity with Agile Scrum, SDLC, GxP Manufacturing Guidelines, GxP Quality Control, and SCADA.
• Experience with MES, SCADA, and SCRUM.
• Strong communication, organizational, and decision-making skills.
• Proven experience in a similar role within the Bio-Pharmaceutical Manufacturing Laboratory domain.
• Knowledge of 21 CFR Part 11, 210, 211, 820 (Quality System Regulations), FDA, Risk Assessment, GAMP 5, Change Control, CAPA, etc.