MES Software Quality Engineer

Cork  ‐ Onsite
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Keywords

Quality Control Change Control Software Quality Supervisory Control and Data Acquisition (SCADA) Manufacturing Pharmaceuticals Scrum Methodology Risk Analysis Testing GXP Title 21 of the Code of Federal Regulations Agile Methodology Computing Platforms Biotechnology Biology Biopharmaceuticals Business Processes Corrective and Preventive Action (CAPA) Medical Laboratory Maintenance Systems Development Life Cycle Quality Management Manufacturing Laboratory Systems Integration Validation Protocols Reliability of Systems

Description

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.
Start date
ASAP
Duration
6 months +
(extension possible)
From
CBS Butler
Published at
03.04.2024
Project ID:
2735191
Contract type
Freelance
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