Computer System Validation Engineer - Lab Systems

Job type:
on-site
Start:
ASAP
Duration:
12 months +
From:
Quanta Consultancy Services
Place:
Dublin
Date:
01/17/2017
Country:
flag_no Ireland
project ID:
1269869

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This project is archived and not active any more.
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Global Bio-Pharmaceutical client have a long term contract requirement for an experienced Computer System Validation Engineer to work on the completion of the 21CFR 11 Assessments on the Laboratory equipment.

This is an exciting new build Bio-pharmaceutical project with enough work to see you through until 2018!
Role and Responsibilities:
  • Support the existing lab facility of a global biotech organisation.
  • The role would require completion of 21 CFR 11 assessments on lab equipment, creation/execution of IQ/OQ documentation, creation of SOP's.
  • Projects will include supporting the qualification of plant computer systems such as Delta V, new plant equipment and also up-grades to existing computer systems and equipment.
  • Quality review and approval of Equipment Validation Protocols including Validation Masterplans, Design documents, Process and Instrumentation Drawings, IQ, OQ, PQ protocols.
  • Participate in GMP Risk Assessments and FMEA's, compliance review of Risk Assessment documentation.
  • Ensure equipment changes are implemented as per change control procedures.
  • Project co-ordination & communication of validation issues to team members & management.
  • Maintaining an up-to-date knowledge of EMA and FDA regulatory requirements.
Requirements:
  • Degree in Engineering/Science Discipline.
  • Experience in computer system validation essential.
  • Labs systems experience essential.
  • Good working knowledge of Regulations and Guidelines, GAMP 5 requirements and ISPE Guidelines.
  • Experience in the Pharmaceutical industry.
  • Ability to participate in cross functional teams.