The role: PE Global is currently recruiting for QC Lab Validation Specialist on behalf of a leading biologics company based in Dublin North. This is an initial 12 month contract role. Description: We are seeking to recruit a QC Lab Validation Specialist to execute Laboratory Instrumentation Purchase, Installation, Qualification and Lifecycle management. Reporting to the QC Instrumentation Team Lead, the specialist will manage the purchase and qualification of laboratory instruments and will be responsible for providing an Instrument Calibration and Maintenance service to the QC laboratory teams. Responsibilities: Providing a Calibration and/or Maintenance Service to the QC laboratory that includes instrumentation calibrations, scheduling and tracking of instrument maintenance and instrument lifecycle management. Review and approve analytical instrumentation qualification, calibration, repairs and documentation. Ensure instrument maintenance and verification is appropriate to the use of the instrument Manage all instrument specific investigations such as calibration deviations Trend lab instrument performance and lifecycle management. Participate in new instrument purchase and qualification Participate as part of a team of QC Specialists, QA validation Specialists and Computer System Validation personnel to deliver on the qualification of new instruments. Liaise with sister sites and vendors on instrumentation purchase, qualification and lifecycle management. Ensure compliance with corporate policies, directives and current regulatory requirements for laboratory instrument qualification, calibration and lifecycle management. Participate in definition and establishment of instrument related procedures. Participate in troubleshooting complex instrumentation issues. Education and Experience: The ideal candidate should hold a minimum of a B.Sc. in scientific related discipline and must have at least 3 years experience, at least 1 of which should be related to instrument qualification experience in a GMP laboratory setting. Previous experience in technology transfers would be advantageous. The candidate must have strong experience in all aspects of instrument management in a GMP environment, in addition to an understanding of the needs and best practices of routine biopharmaceutical drug product and drug substance laboratories. They will have responsibility for establishment of project plans and instrument qualification procedures. Experience in Data Integrity management (21 CFR 11/EU Annex 11) is desired. A strong fundamental understanding of protein biochemistry is desirable, in addition to technical expertise in the following Biopharmaceutical analytical platforms (HPLC/UPLC, CE, cIEF, SDS-PAGE, Biacore, HIAC, KF, Liquid Handlers). The successful candidate must demonstrate the ability to contribute to and lead in a team based collaborative environment, as well as the ability to prioritise objectives from multiple projects. The successful candidate must demonstrate time management and organisational skills and excellent communication is essential. Interested candidates should submit an updated CV. Please click the link below to apply, call Kellie on or alternatively send an up to date CV to ***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland*** Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. Skills: quality control validation equipment lab systems
