{"schemaVersion":"jobsearcher.job.v1","id":"fd98d6bff3b43e44c07aede3","url":"https://jobsearcher.com/jobs/fd98d6bff3b43e44c07aede3","canonicalUrl":"https://jobsearcher.com/jobs/fd98d6bff3b43e44c07aede3","title":"CSV Engineer","description":"What 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.\n\nWe are actively expanding our US projects team to support a growing portfolio of pharmaceutical and biotechnology projects across the United States. SimoTech is seeking an Automation CSV Engineer to join our team. The successful candidate will support the validation of computerised systems within the process automation framework, ensuring their compliance with pharmaceutical industry standards and regulations. The ideal candidate will have extensive experience as a CSV Engineer in a pharmaceutical environment.\n\nKey Responsibilities\n\nDevelop and execute validation strategies for new and existing process automation and computerised systems.\n\nSupport the implementation and validation of DeltaV, Siemens PLC, PI and other automation platforms.\n\nPrepare and review validation documents including URS, FRS, IQ, OQ, PQ, Validation Plans, Summary Reports and Automation Change Pack (ACP’s).\n\nDevelop and execute PV and PQ protocols to support readiness for commercial manufacturing.\n\nPerform risk assessments, impact assessments, and manage change controls for validated systems.\n\nCreate and maintain traceability matrices ensuring full alignment between requirements, design, and testing.\n\nIdentify, troubleshoot, and resolve validation deviations and test failures in a timely manner.\n\nExecute commissioning and qualification test cases to verify system functionality and data integrity.\n\nSupport internal audits, inspection readiness, and preparation activities for regulatory licensure (HPRA, EMA, FDA).\n\nEnsure all validation work complies with 21 CFR Part 11, GAMP 5, EU Annex 11, and site quality standards.\n\nCollaborate with IT QA to ensure compliance and drive continuous improvement in validation processes.\n\nProvide validation and regulatory training to team members to support the transition from project phase to operations.\n\nKey Requirements\n\nBachelor’s Degree in Engineering, Information Systems, Computer Science or Life Sciences.\n\nMinimum of 5 years’ experience as a CSV Engineer in a pharmaceutical environment.\n\nExperience supporting process automation systems and manufacturing technologies from a CSV perspective.\n\nGood knowledge of 21 CFR Part 11, EU Annex 11, GAMP5 and data integrity guidelines.\n\nHands on experience validating DeltaV and Siemens PLC automated systems.\n\nExcellent Communication and stakeholder management skills.\n\nAbility to work independently while contributing effectively within a team environment.\n\nEligibility to work in the United States.\n\nWhat SimoTech Can Offer\n\nOpportunity to work with large corporate clients on exciting capital projects.\n\nRole provides a high degree of autonomy to allow the successful candidate to reach their full potential.\n\nDevelop new skills and enhance technical ability by working with innovative technologies in.\n\nWe offer a hybrid working model for this role, balancing flexibility with business needs.\n\n#J-18808-Ljbffr","company":"Simotech","rawCompany":"simotech","city":"Virginia","state":"MN","isRemote":false,"isActive":false,"createdAt":"2026-04-11T03:06:07.039Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"15-1253.00","title":"Software Quality Assurance Analysts and Testers","slug":"software-quality-assurance-analysts-and-testers"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"}],"industries":[{"code":"541330","title":"Engineering Services","slug":"engineering-services"},{"code":"541690","title":"Other Scientific and Technical Consulting Services","slug":"other-scientific-and-technical-consulting-services"},{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"CSV Engineer","description":"What 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.\n\nWe are actively expanding our US projects team to support a growing portfolio of pharmaceutical and biotechnology projects across the United States. SimoTech is seeking an Automation CSV Engineer to join our team. The successful candidate will support the validation of computerised systems within the process automation framework, ensuring their compliance with pharmaceutical industry standards and regulations. The ideal candidate will have extensive experience as a CSV Engineer in a pharmaceutical environment.\n\nKey Responsibilities\n\nDevelop and execute validation strategies for new and existing process automation and computerised systems.\n\nSupport the implementation and validation of DeltaV, Siemens PLC, PI and other automation platforms.\n\nPrepare and review validation documents including URS, FRS, IQ, OQ, PQ, Validation Plans, Summary Reports and Automation Change Pack (ACP’s).\n\nDevelop and execute PV and PQ protocols to support readiness for commercial manufacturing.\n\nPerform risk assessments, impact assessments, and manage change controls for validated systems.\n\nCreate and maintain traceability matrices ensuring full alignment between requirements, design, and testing.\n\nIdentify, troubleshoot, and resolve validation deviations and test failures in a timely manner.\n\nExecute commissioning and qualification test cases to verify system functionality and data integrity.\n\nSupport internal audits, inspection readiness, and preparation activities for regulatory licensure (HPRA, EMA, FDA).\n\nEnsure all validation work complies with 21 CFR Part 11, GAMP 5, EU Annex 11, and site quality standards.\n\nCollaborate with IT QA to ensure compliance and drive continuous improvement in validation processes.\n\nProvide validation and regulatory training to team members to support the transition from project phase to operations.\n\nKey Requirements\n\nBachelor’s Degree in Engineering, Information Systems, Computer Science or Life Sciences.\n\nMinimum of 5 years’ experience as a CSV Engineer in a pharmaceutical environment.\n\nExperience supporting process automation systems and manufacturing technologies from a CSV perspective.\n\nGood knowledge of 21 CFR Part 11, EU Annex 11, GAMP5 and data integrity guidelines.\n\nHands on experience validating DeltaV and Siemens PLC automated systems.\n\nExcellent Communication and stakeholder management skills.\n\nAbility to work independently while contributing effectively within a team environment.\n\nEligibility to work in the United States.\n\nWhat SimoTech Can Offer\n\nOpportunity to work with large corporate clients on exciting capital projects.\n\nRole provides a high degree of autonomy to allow the successful candidate to reach their full potential.\n\nDevelop new skills and enhance technical ability by working with innovative technologies in.\n\nWe offer a hybrid working model for this role, balancing flexibility with business needs.\n\n#J-18808-Ljbffr","datePosted":"2026-04-11T03:06:07.039Z","dateModified":"2026-04-11T03:06:07.039Z","hiringOrganization":{"@type":"Organization","name":"Simotech","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Virginia","addressRegion":"MN","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"fd98d6bff3b43e44c07aede3"},"url":"https://jobsearcher.com/jobs/fd98d6bff3b43e44c07aede3"}}