PE Global is recruiting for a Lab IT Analyst for a leading multinational biopharmaceutical client in Dublin.
This is a hybrid role. The ideal candidate will have laboratory experience in biopharma and familiarity with lab software applications, particularly the use of an ELN (electronic notebook) and validation testing of GxP software.
Job Summary The candidate will execute deliverables for a project to implement a new, fully Electronic Lab Notebook (ELN) system.
This is a non-laboratory testing position.
This position will be responsible for performing activities towards the design, configuration, and validation of the new ELN system, recreation and/or migration of required master data, and involvement in the deployment of production instances at the site(s).
This position will be expected to adhere to established procedures (Standard Operating Procedure, Work Instruction) for safety and cGMP/CFR requirements, which includes, but is not limited to, expectations of training and documentation practices.
This position will work in a team environment, collaborating with various colleagues in the network to ensure project commitments are met.
They will report status/updates of key responsibilities and escalate any issues through the project management team.
Key Responsibilities for the new ELN system: Participate in process engineering activitiesFacilitate the development of new business SOPs, Forms, Manuals, etc.
using new processes/workflowsParticipate in system requirement, software configuration, and design activitiesReceive and/or verify master data for the site(s)Coordinate ELN Template development and review with site SMEsSupport the development and review of Operational QualificationsExecute User Acceptance Testing & Data Migration VerificationReview and provide input on training materialsSupport training material development by providing inputs and reviewsSupport site Instrument Qualification activities such as planning and executionBasic Qualifications Bachelor's degree and 3 years of industry Quality Control or Quality experiencePreferred Qualifications (Top 3 first, listed in order) GxP experience, specifically practices and requirements in the testing of biopharmaceuticals.Experience in development and validation testing of software used in a GMP environment.Experience and knowledge in using electronic lab notebook systems (Biovia OneLab, Thermo Fisher Sample Manager, LabWare, Benchling, etc.
).Experience in the use of other industry systems such as Veeva & Empower.Experience in testing or with processes involving analytical methods.Proficient in Microsoft Office (i.e., Outlook, Word, Excel, PowerPoint).Excellent problem-solving capabilities and attention to detail.Experience of collaboration within and across functional areas.Excellent written and verbal communication skills.Interested candidates should submit an updated CV. Please click the link below to apply, call Paul Wheatley on 083 094 0199, 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.
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