CSV Engineer, Cork As the Computer Systems Validation Engineer, you will work on large projects for one of Ireland's most prominent Pharma manufacturing sites. You, undoubtedly, will be familiar with this client and their fantastic company reputation.You will be responsible for the Computer System Validation of IT solutions being implemented and will provide IT systems validation and compliance expertise for newly introduced IT and digital solutions.The position will work within a collaborative team and will be required to have excellent communication/interpersonal skills with the ability to work on their own initiative.Experience of working in a pharmaceutical API manufacturing operation or a regulated environment requiredMonday-Friday, days role. This role will start ASAP (ideally)
My client is a market leader in manufacturing solutions within the Biopharma & Pharmaceutical industries and they are looking for dedicated, innovative and driven talent to join their expanding teams.
A little about the role …
Permanent position with excellent benefits package and career progression opportunities!
Manage the Computer System Validation aspect of IT projects from software install to business releaseLiaise with service providers and IT team to determine successful installation of software and ensure correct configurationResponsibility for server installations and system related activities e.g. security, admin config settings, access permissionsGenerate computer system validation documentation in accordance with site procedures and GMP guidelinesExecute test scripts, analyze test results and determine the acceptability of results against pre-determined criteriaWork with the business to identify and implement procedural controls to mitigate issues found during testingInitiate and implement Change Control activities in accordance with Quality Standards and PracticesDetermine solutions or recommendations for changes and/or improvementsPrioritize validation activities in line with the project scheduleCollaborating with global IT and Quality teams
You will have the following …
Relevant Bachelors degree5 years relevant experience in a CSV role, working on projects within GMP Biopharma/Pharmaceutical Industry an absolute requirementMinimum 5 years experience implementing IT solutions, systems integration, support & validating IT applications and interfacesExperience of writing validation plans, requirements gathering, design documentation, system configuration, system testing and troubleshootingKnowledge of 21CFR Part 11 requirements, ER/ES and data integrity guidelinesExperience of OSI PI is an advantageExperience of data analytics and reporting solutions is an advantageExperience of server and workstation platforms and working in a Win 10 environmentStrong oral and written communication skills are required, with proven ability to communicate and build relationships cross-functionallySelf-motivated, detail-oriented and excellent organizational and time management skills
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Contact Dara Bradley or email your CVmore information and/or to review the full job spec. I would be delighted to guide you through the whole process…
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