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Ruth Holland
Life Science

01 507 9255
[email protected]
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Details

Validation Engineer


Reference:/RH/ACHI-826877 Location: Wicklow
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: EHS Engineer, Validation Coordinator, Validation Engineer, Validation Specialist

Life Science Recruitment are recruiting a Validation Engineer to join the team with our Pharmaceutical client based in Wicklow.


Specific Areas of Responsibility include:


Operational :

  • Preparation of Installation Qualification and Operations Qualification (IQ and OQ) protocols for all new engineering projects and liaise with the relevant Q.A. personnel to define the requirements of the protocols.
  • Execution of IQ and OQ qualification/ validation tests.
  • Complete qualification/ validation reports and summary reports and submit them to relevant Q.A. for approval.
  • Advise relevant Q.A. personnel of the validation requirements for the Engineering Department.
  • Represent the Engineering Department in the Validation Group Meeting and act as the point of contact in the Engineering team for Validation/Quality issues.
  • Review documentation written by members of the Engineering Department to ensure that they adhere to the Validation protocols and Company policies.
  • Act in an advisory capacity for the Engineering Department on all quality/ validation issues for specific projects.
  • Liaise with Project Engineers and relevant Q.A. personnel to complete project documentation within defined time frames.
  • Complete and update a library for validation documentation/ guidelines.
  • Maintain the Change Control System for the Engineering Department.
  • Policy and decision maker for Calibration and Metrology while complying with GAMP Guidelines and Good Weigh Practice.
Team work :
  • Work co-operatively and flexibly both within your department and with other departments.
  • Be prepared to undertake additional tasks as requested to meet operational or business requirements.

Health, Safety, Environment & Quality :
  • Observe all GMP, safety & environmental requirements. Emphasise these standards / norms to visitors and request that they adhere to them.

Other Duties :
  • Partake in any in-house or external training deemed to be necessary or enhancing for the carrying out of your function and the development of your role within the Company.
  • Participate in cross departmental working groups / project teams as may be requested from time to time.
  • Be prepared to undertake additional duties as requested.
Experience / Competencies / Skills:


Essential:
  • Degree in a Life Science, Engineering or equivalent
  • 2-3 years’ experience in qualification/validation
  • Good I.T. skills
  • Strong leadership, planning, communication and interpersonal skills
  • Experience in a qualification/ validation is a pre-requisite for this position

Desirable:
  • AutoCAD skills / Ability to read drawings (building layouts / mechanical services)


For more information contact Ruth Holland on 087 7822198 or [email protected]