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.

• 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.

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

• 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.

• 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

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