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Csv engineer 1642

Dundalk
SimoTech
Engineer
Posted: 22 January
Offer description

Why SimoTechWhat is it like to work at SimoTech? With a strong collaborative teamwork culture based on respect, trust, and excellence, we play a critical partnering role to our clients' life-changing supply of products to patients. In return, there is excellent salary, benefits, career progression, educational support and much more.****CSV Engineer 1642SimoTech have an opportunity for a CSV Engineer to join our team, working on a state-of-the-art greenfield biotechnology site based in Co. Louth.The successful candidate would have 1 - 3 years' experience working in a CSV environment within the biotechnology or pharmaceutical industry. This will be a fully onsite role.****Key ResponsibilitiesSupport the creation, review, and execution of CSV documentation deliverables for DeltaV software upgrade projects.Assist in the validation of digitalisation platforms, including E-Signature, E-Forms, and E-Logbooks, ensuring compliance with regulatory standards.Participate in network integration and validation of standalone benchtop systems such as Vi-Cells, FIT analysers, Shimadzu instruments to ensure data integrity and connectivity.Prepare and maintain CSV protocols, test scripts, and reports for system qualification and validation activities.Collaborate with cross-functional teams to ensure timely completion of validation tasks and adherence to project timelines.Assist in troubleshooting and resolving validation-related issues during system implementation and upgrades.Ensure compliance with company SOPs, industry standards, and regulatory guidelines throughout all validation activities.Maintain accurate documentation and support audits by providing validation evidence as required.QualificationsRequirements**Qualifications & ExperienceBachelor's degree in Engineering, Computer Science or Life Sciences.Minimum 1 year of relevant validation experience within the biotechnology or pharmaceutical industry.Solid understanding of regulatory compliance requirements in a pharmaceutical environment.Good knowledge of digital platforms such as E-Signature, E-Forms, and E-Logbooks.Hands-on experience in validation of standalone benchtop systems.Proficiency in using quality systems for documentation and compliance.Demonstrate accuracy and attention to detail, combined with strong planning and organisational skills to manage documentation control, execute tasks, and adapt to changing priorities.BenefitsBenefits**What SimoTech Can OfferRole provides a high degree of autonomy to allow the successful candidate to reach their full potential.Develop new skills and enhance technical ability by working with innovative technologies in a multi- disciplined environment.Opportunity to work with large corporate clients****

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