Computer Systems Validation Engineer

Job type:
on-site
Start:
Immediate
Duration:
6 months
From:
E-Frontiers
Place:
Waterford
Date:
05/22/2013
Country:
flag_no United Kingdom
project ID:
540006

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Computer Systems Validation Engineer

Purpose of Role

The Computer Systems Validation Engineer role is to support execution of Computer Systems Remediation Project, identifying and remediating gaps in computer systems and ensuring compliance to corporate standard for Computer Systems Lifecycle. This includes ERES Assessment, Lifecycle Documentation, DRP, Security and Access etc.

Accountabilities

  • Execute to project plan across a broad range of cGMP Computer Systems
  • Liaise with key stakeholders
  • Provide technical input to remediation activities
  • Ensure that the validation status of computer systems, associated equipment and processes are maintained in compliance with cGMP.

Skills & Knowledge

  • Able to execute projects to plan, working in a cross-functional team
  • Capable of troubleshooting validation issues with Computer Systems
  • Competent technical knowledge of pharmaceutical plants
  • Full understanding of relevant quality and compliance regulations
  • Good knowledge of quality management systems, including change control
  • Good communication skills at organization, team and individual levels

Education:

3rd Level Qualification in Computer Systems Science or Engineering (or related discipline).

Experience

You will have 2 to 5 years experience working in the pharmaceutical or biotechnology sector. Computer systems design/testing/user management control. Experience of Computer Systems Remediation.