**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 in our clients' life-changing supply of products to patients. In return, there is an excellent salary, benefits, career progression, educational support and much more.**CSV EngineerSimoTech is seeking a Junior/Intermediate Computer Systems Validation (CSV Engineer) to join our Cork headquarters. This is an exciting opportunity to work with a team of technical experts on projects that accelerate the delivery of life-changing medicines. SimoTech working with clients in the pharma and biotech sector can offer hands-on experience in a regulated environment, career development and exposure to cutting-edge technologies.The ideal candidate will be detail oriented, eager to learn regulatory compliance and comfortable working within structured processes. You should be a team player who can adapt to changing priorities and demonstrates a technical interest or background that supports your growth in this role.**Key ResponsibilitiesAssist with tasks required to ensure that computerised systems in regulated environments remain compliant to FDA and EU regulatory and internal quality standards.Validation deliverables; Develop, review and execution of validation documents and protocols. E.g. URS, Test Scripts, Validation Plan and Summary Reports.Support risk assessments for new or retiring systems to ensure data integrity.Ensure compliance with GxP, FDA and EU regulatory guidelines.Teamwork: work closely with cross-functional teams, i.e. Engineering, Quality and manufacturing.Requirements**Key RequirementsBachelor's degree in engineering, Computer Science or related science discipline.2-4 years experience in a related role.Basic understanding of CSV principles, GAMP guidance and regulatory requirements.Awareness of FDA 21 CFR Part 11 and EU Annex 11 and data integrity principles.Familiar with System Development Life Cycle (SDLC) concepts.Strong communication skills and attention to detail.Proficiency in Microsoft Office (Word, Excel), exposure to LIMS/Lab benchtop/Automation systems is a plus.Benefits****What SimoTech Can OfferRole provides a high degree of autonomy to allow the successful candidate to reach their full potential.Long term project opportunity.SimoTech can facilitate these positions as a staff engineer or contract engineer.Competitive staff or contract rates.**