Senior Lead MES Validation Engineer


Our client, a leading multinational, is seeking a Senior Lead MES Validation Engineer with Manufacturing Execution Systems (MES) experience within the Life Science, Pharmaceutical or Biotech industry. This opportunity will see you join an industry leader in deployment of Manufacturing Systems for the Life Science Manufacturing industry for an initial 6-month contract based in Dublin or Cork.

Dublin Or Cork

Contract

€400 - €550 p/d

JCAC3

RESPONSIBILITIES

  • Lead validation activities in the implementation of Manufacturing Execution Systems (MES) and Electronic Batch Records (EBR).
  • Work closely with business management and validation departments to strategically define validation approaches and solutions that add value to clients, and to project delivery.
  • Partner with business clients and multi-disciplinary Accenture delivery teams to determine appropriate validation strategy and approach for specific MES projects (including interfaces to other systems).
  • Develop or provide guidance on the Validation deliverables including Quality Assurance Plans, Validation and Testing Plans, Design Documents, Test Protocols and Summary Reports, Traceability Matrix etc.
  • Co-ordinate and conduct informal and formal testing of MES solutions.
  • Execution, Review and Approval of Validation documents, including Exception/Deviation management
  • Direct the validation activities of team in the above tasks

REQUIREMENTS

  • Bachelors’ degree in Science, Engineering or relatable technical degree
  • 5+ years validation experience in a highly automated Life Sciences manufacturing environment
  • Knowledge of FDA and GMP guidelines a necessity
  • Working knowledge of software Development Life Cycle (SDLC) and support methodologies required.
  • Understanding of Life Sciences Computer System validation processes.
  • Experience with PAS|X, Syncade, PharmaSuite, XFP, POMS, Camstar or other life sciences compatible MES solutions, a distinct advantage
  • A strong collaborator, able to facilitate client and internal stakeholder meetings and agendas, outcome focused and team-orientated
  • Strong written and oral communication skills

Submit your CV