CSV Engineer - Lab Systems

Dublin  ‐ Onsite
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Description

We require a CSV Engineer to support the existing lab facility of a global biotech organisation, based near Dublin, for a 12 month contract. The Validation Engineer will be responsible for the completion of 21 CFR 11 assessments on lab equipment, creation/execution of IQ/OQ documentation, creation of SOP's.
Role and Responsibilities:
  • 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 plus 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.
If this is you, please apply today.
Start date
ASAP
Duration
12 months
From
Quanta Consultancy Services
Published at
22.07.2017
Project ID:
1385632
Contract type
Freelance
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