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CSV Engineer

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Limerick
  • Sector: Engineering
  • Date posted: 09/05/2018
  • Job reference: J386105A

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Experis are currently recruiting for a CSV Engineer for an exciting opportunity with a bio-pharmaceutical manufacturing company in Ireland's south-west.
The successful candidate for this position will be tasked with implementing policies and procedures to validate/qualify computer systems. The work will involve planning, coordinating, and participating in a compliant validation process for quality information technology systems which require formal validation documentation under appropriate regulatory requirements and company manufacturing standards.

Essential Duties and Responsibilities include, but are not limited to, the following:

  • Analysing the results of testing and determines the acceptability of results against predetermined criteria.
  • Investigating and troubleshooting problems which occur and determine solutions or recommendations for changes and/or improvements.
  • Identify current and anticipated requirements for compliant computerised operations and suggest methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation.
  • Lead process improvement projects to improve the validation of computerised systems
  • Co-ordinate with other departments or outside contractors/vendors to complete validation tasks.
  • Participate in regulatory audits and communicate company's computer validation policies.
  • Assess company's computer systems and identify any potential Part 11 or Annex 11 gaps and ensure best data integrity practices are enforced.
  • Train / advise less experienced Specialists and Technicians.
  • Possess a thorough understanding and experience of Validation Principles with good knowledge of GAMP 5, ICH Q7A, FDA parts 210 and 211.
  • Technical writing experience.
  • Generation of Validation documents.
  • Review and Approval of Validation documents.
  • Strong attention to detail and accuracy.
  • Experience in risk assessments in relation to validation activities.
  • Advise and support all teams on computer validation activities.

Education and Experience:

  • Requires BS/BA in Engineering, Chemistry, or Life Sciences with 3+ years of related experience within the fields of computers and biotechnology; will substitute relevant experience for education.
  • Experience with process control systems necessary.

If you are interested in this role or in other similar positions, please contact Dominic on 01 645 5254 or at for further info

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