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
