{"schemaVersion":"jobsearcher.job.v1","id":"34f282d84708c4a6e286f7ec","url":"https://jobsearcher.com/jobs/34f282d84708c4a6e286f7ec","canonicalUrl":"https://jobsearcher.com/jobs/34f282d84708c4a6e286f7ec","title":"Engineering Technical Leads ETL","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:\nEngineering Technical Leads ETLs\nProject Scope:\nProvide ETL Support Services.\nPreparation of front-end planning documents.\nLead the design process.\nProvide value engineering / creative problem solving.\nParticipation in the development of the sourcing strategy for projects.\nEvaluate the design library against the project scope and issue relevant specifications or standards.\nReview of the projects plans for adherence to Amgen engineering standards and specifications\nIdentification of possible deviations to the site specifications. Submittal and approval of variance.\nEnsure Factory Mutual loss prevention recommendations are issued and addressed in the design.\nEnsure EHSS requirements are considered in the design.\nTechnical support during project execution and lead for discrepancies.\nLiaison to engineering technical authorities, subject matter experts, consultants, and engineer of record.\nRFI and submittal review process.\nTrack design progress against plan and ensure alignment with overall project’s schedule.\nEngineering change management.\nConsultant to site commissioning and qualification work stream.\nConsultant to site change control evaluation process.\nPoint of contact between equipment vendors and the site.\nEstablish method to manage information and documents. e-Builder preferred for capital projects.\nFactory acceptance test planning.\nEnsure project plans and details are fit to introduce equipment.\nDevelop, submit, and approve design qualification report (for level 1 systems), and DDR for level 2 and 3.\nDelivery Criteria\nProvide ETL Support Services to support the project\nScope of facilities\nProject requirements\nDesign Plan\nDesign review reports\nDesign qualification report\nConceptual design documents\ne-Builder processes\nSubmittals\nRFIs\nTurnover packages\nEngineering Change Notices\nOther Activities\nField visits to confirm existing documentation and installations.\nQualifications:\nBachelor's Degree in Science or Engineering.\nMinimum of 5 years of experience in direct pharmaceutical, medical device or biotechnology industries.\nMust be fully bilingual (English / Spanish) with excellent oral skills.\nStrong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.\nTechnical Writing skills and investigations processes.\nAvailable to work extended hours, possibility of weekends and holidays.\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.\n#LI-ZL1","company":"Validation","rawCompany":"validation","city":"Juncos","state":"PR","isRemote":false,"isActive":false,"createdAt":"2026-08-01T06:53:39.338Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"11-9041.00","title":"Architectural and Engineering Managers","slug":"architectural-and-engineering-managers"},{"code":"17-2199.00","title":"Engineers, All Other","slug":"engineers-all-other"}],"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":"541380","title":"Testing Laboratories and Services","slug":"testing-laboratories-and-services"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Engineering Technical Leads ETL","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:\nEngineering Technical Leads ETLs\nProject Scope:\nProvide ETL Support Services.\nPreparation of front-end planning documents.\nLead the design process.\nProvide value engineering / creative problem solving.\nParticipation in the development of the sourcing strategy for projects.\nEvaluate the design library against the project scope and issue relevant specifications or standards.\nReview of the projects plans for adherence to Amgen engineering standards and specifications\nIdentification of possible deviations to the site specifications. Submittal and approval of variance.\nEnsure Factory Mutual loss prevention recommendations are issued and addressed in the design.\nEnsure EHSS requirements are considered in the design.\nTechnical support during project execution and lead for discrepancies.\nLiaison to engineering technical authorities, subject matter experts, consultants, and engineer of record.\nRFI and submittal review process.\nTrack design progress against plan and ensure alignment with overall project’s schedule.\nEngineering change management.\nConsultant to site commissioning and qualification work stream.\nConsultant to site change control evaluation process.\nPoint of contact between equipment vendors and the site.\nEstablish method to manage information and documents. e-Builder preferred for capital projects.\nFactory acceptance test planning.\nEnsure project plans and details are fit to introduce equipment.\nDevelop, submit, and approve design qualification report (for level 1 systems), and DDR for level 2 and 3.\nDelivery Criteria\nProvide ETL Support Services to support the project\nScope of facilities\nProject requirements\nDesign Plan\nDesign review reports\nDesign qualification report\nConceptual design documents\ne-Builder processes\nSubmittals\nRFIs\nTurnover packages\nEngineering Change Notices\nOther Activities\nField visits to confirm existing documentation and installations.\nQualifications:\nBachelor's Degree in Science or Engineering.\nMinimum of 5 years of experience in direct pharmaceutical, medical device or biotechnology industries.\nMust be fully bilingual (English / Spanish) with excellent oral skills.\nStrong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.\nTechnical Writing skills and investigations processes.\nAvailable to work extended hours, possibility of weekends and holidays.\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.\n#LI-ZL1","datePosted":"2026-08-01T06:53:39.338Z","dateModified":"2026-08-01T06:53:39.338Z","hiringOrganization":{"@type":"Organization","name":"Validation","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Juncos","addressRegion":"PR","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"34f282d84708c4a6e286f7ec"},"url":"https://jobsearcher.com/jobs/34f282d84708c4a6e286f7ec"}}