{"schemaVersion":"jobsearcher.job.v1","id":"1bf6d56e38628595721fa0ec","url":"https://jobsearcher.com/jobs/1bf6d56e38628595721fa0ec","canonicalUrl":"https://jobsearcher.com/jobs/1bf6d56e38628595721fa0ec","title":"Validation Engineer","description":"Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.\nWe are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:\nValidation Engineer\nDescription:\nThis position supports equipment design and process implementation activities under the guidance of the Staff Engineer. The Senior Engineer leads the design, development, validation, and integration of manufacturing equipment, ensuring full alignment with project requirements, regulatory standards, and operational excellence in a GMP-regulated environment.\nThe role demands deep technical expertise across the full validation lifecycle — including URS development, FAT/SAT execution, and Computer System Validation (CSV) — as well as hands-on experience with PLC systems and controls integration. The candidate will drive end-to-end project implementation: from equipment design and installation through startup, commissioning, and qualification.\nThis position requires the ability to work independently while partnering with cross-functional teams (Engineering, Quality, Operations) and external vendors, with willingness to travel domestically and internationally up to 25% (Philadelphia, Rhode Island, Germany, Japan).\nKey Responsibilities:\nDevelop User Requirement Specifications (URS) and mechanical/electrical designs for assembly and packaging equipment.\nLead full validation lifecycle activities: FAT, SAT, CSV, equipment integration, and startup.\nDrive process design for new equipment and ensure product design requirements are met.\nExecute commissioning and qualification activities for new and existing equipment.\nProvide technical oversight to ensure equipment meets safety, regulatory, and operational standards.\nManage suppliers and external vendors on capital projects, controlling scope, cost, and lead time.\nCollaborate with Procurement and Legal on vendor contracts.\nDevelop detailed 3D models and 2D drawings using CAD tools (AutoCAD, SolidWorks).\nCreate and maintain engineering documentation (URS, assembly instructions, bill of process, etc.).\nOptimize equipment design for manufacturability, cost reduction, maintainability, and efficiency.\nLead design reviews, risk assessments, and FMEA to ensure reliability and performance.\nPerform engineering analyses (stress, strain, thermal, fluid dynamics) to validate designs.\nEnsure seamless integration of mechanical systems with electrical, controls, and maintenance teams.\nSupport PLC systems and controls integration as part of equipment implementation.\nExecute capital projects in GMP manufacturing environments.\nEnsure compliance with all safety regulations and quality policies, procedures, and GMP standards.\nApply statistical analysis and SPC systems to support data-driven decision-making.\nManage multiple priorities and maintain equipment qualification schedules.\nQualifications:\nBachelor's degree in Mechanical, Electrical, Chemical, or Industrial Engineering (Master's preferred).\nMinimum 8 years of engineering experience in pharmaceutical and/or medical device industries.\nDemonstrated experience across the full validation lifecycle (URS, FAT, SAT, CSV).\nExperience with PLC programming and controls integration.\nProven track record supporting full project implementation: design, installation, startup, commissioning, and qualification.\nStrong experience executing capital projects within GMP-regulated manufacturing environments.\nProficiency in AutoCAD and/or SolidWorks.\nStrong analytical and problem-solving skills, including FMEA and statistical analysis/SPC.\nFamiliarity with GMP, ISO standards, Lean Manufacturing, and FDA-regulated environments.\nAbility to work independently and lead solutions under general direction.\nStrong project management, organization, and communication skills.\nWillingness and ability to travel domestically and internationally up to 25%.\nAt Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.\n\nExcited to build something meaningful together? We look forward to hearing from you.\n\nValidation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.","company":"Validation","rawCompany":"validation","city":"Humacao","state":"PR","isRemote":false,"isActive":false,"createdAt":"2026-07-19T14:01:06.040Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"17-2199.00","title":"Engineers, All Other","slug":"engineers-all-other"},{"code":"17-2031.00","title":"Bioengineers and Biomedical Engineers","slug":"bioengineers-and-biomedical-engineers"}],"industries":[{"code":"541330","title":"Engineering Services","slug":"engineering-services"},{"code":"333248","title":"All Other Industrial Machinery Manufacturing","slug":"all-other-industrial-machinery-manufacturing"},{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Validation Engineer","description":"Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.\nWe are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:\nValidation Engineer\nDescription:\nThis position supports equipment design and process implementation activities under the guidance of the Staff Engineer. The Senior Engineer leads the design, development, validation, and integration of manufacturing equipment, ensuring full alignment with project requirements, regulatory standards, and operational excellence in a GMP-regulated environment.\nThe role demands deep technical expertise across the full validation lifecycle — including URS development, FAT/SAT execution, and Computer System Validation (CSV) — as well as hands-on experience with PLC systems and controls integration. The candidate will drive end-to-end project implementation: from equipment design and installation through startup, commissioning, and qualification.\nThis position requires the ability to work independently while partnering with cross-functional teams (Engineering, Quality, Operations) and external vendors, with willingness to travel domestically and internationally up to 25% (Philadelphia, Rhode Island, Germany, Japan).\nKey Responsibilities:\nDevelop User Requirement Specifications (URS) and mechanical/electrical designs for assembly and packaging equipment.\nLead full validation lifecycle activities: FAT, SAT, CSV, equipment integration, and startup.\nDrive process design for new equipment and ensure product design requirements are met.\nExecute commissioning and qualification activities for new and existing equipment.\nProvide technical oversight to ensure equipment meets safety, regulatory, and operational standards.\nManage suppliers and external vendors on capital projects, controlling scope, cost, and lead time.\nCollaborate with Procurement and Legal on vendor contracts.\nDevelop detailed 3D models and 2D drawings using CAD tools (AutoCAD, SolidWorks).\nCreate and maintain engineering documentation (URS, assembly instructions, bill of process, etc.).\nOptimize equipment design for manufacturability, cost reduction, maintainability, and efficiency.\nLead design reviews, risk assessments, and FMEA to ensure reliability and performance.\nPerform engineering analyses (stress, strain, thermal, fluid dynamics) to validate designs.\nEnsure seamless integration of mechanical systems with electrical, controls, and maintenance teams.\nSupport PLC systems and controls integration as part of equipment implementation.\nExecute capital projects in GMP manufacturing environments.\nEnsure compliance with all safety regulations and quality policies, procedures, and GMP standards.\nApply statistical analysis and SPC systems to support data-driven decision-making.\nManage multiple priorities and maintain equipment qualification schedules.\nQualifications:\nBachelor's degree in Mechanical, Electrical, Chemical, or Industrial Engineering (Master's preferred).\nMinimum 8 years of engineering experience in pharmaceutical and/or medical device industries.\nDemonstrated experience across the full validation lifecycle (URS, FAT, SAT, CSV).\nExperience with PLC programming and controls integration.\nProven track record supporting full project implementation: design, installation, startup, commissioning, and qualification.\nStrong experience executing capital projects within GMP-regulated manufacturing environments.\nProficiency in AutoCAD and/or SolidWorks.\nStrong analytical and problem-solving skills, including FMEA and statistical analysis/SPC.\nFamiliarity with GMP, ISO standards, Lean Manufacturing, and FDA-regulated environments.\nAbility to work independently and lead solutions under general direction.\nStrong project management, organization, and communication skills.\nWillingness and ability to travel domestically and internationally up to 25%.\nAt Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.\n\nExcited to build something meaningful together? We look forward to hearing from you.\n\nValidation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.","datePosted":"2026-07-19T14:01:06.040Z","dateModified":"2026-07-19T14:01:06.040Z","hiringOrganization":{"@type":"Organization","name":"Validation","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Humacao","addressRegion":"PR","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"1bf6d56e38628595721fa0ec"},"url":"https://jobsearcher.com/jobs/1bf6d56e38628595721fa0ec"}}