Ellie Butt

CSV Engineer - Ireland, Limerick - 12 Months Initial ContractLooking to take your career to the next level? We’re recruiting for a high-impact pharmaceutical project located near Limerick. With major capital investment experience driving various facility build projects. This is a unique opportunity for a CSV Engineer to join a global leader in the life sciences market and play a key role in shaping the future of advanced manufacturing. What you’ll do: Support operational team with Validation planning and executionEnsure Regulatory complianceAssist with system testing and verificationProvide full system lifecycle managementCarry out accurate documentation and reporting What you’ll need: Extensive CSV experience within a pharmaceutical / biotech industry.Experience with process automation systems and manufacturing technologiesKnowledge of regulatory requirementsExperience with automated system validation Don’t miss your chance to be part of something extraordinary, apply now and let’s talk!

Lab CSV Engineer - Dublin, Ireland - 12 Month ContractOne of the top 10 best companies to work in Ireland is looking for a Lab CSV Engineer for their large-scale new facility in Dublin. Is this you? An exciting project there is lots of opportunity to learn new technology and develop current skills within a fast paced €1 billion project. This fantastic client offers the opportunity to work within a large-scale environment with cutting edge technology. What you’ll do: Develop and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for computer systems and software applications.Collaborate with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure compliance with regulatory guidelines and internal policies.Perform risk assessments and impact analyses to identify critical system functionalities and potential vulnerabilities.Create and maintain validation documentation, such as validation plans, test scripts, traceability matrices, and validation summary reports.Conduct periodic reviews to ensure ongoing compliance with regulatory requirements and internal procedures. What you’ll need: Bachelor's degree in Computer Science, Engineering, or a related field.Experienced in computer systems validation (CSV) from requirements to through release of analytical instruments used in Quality Control (QC) laboratories or in manufacturing operations as part of Process analytical Technology (PAT).Experienced in computer systems validation (CSV) of server / database-based laboratory software, middleware and enterprise applications, for example LIMS, Empower, NuGenesis.Completion of Electronic Record Electronic Signatures (ERES) assessments and Data Integrity Risk Assessments for analytical instruments and software systems.Experienced in the use of paperless validation and test tools such as ValGenesis, Kneat, ALM.  If this role is of interest, please apply now!#LI-JS4