{"schemaVersion":"jobsearcher.job.v1","id":"1957eb8da0a26e0c031aee76","url":"https://jobsearcher.com/jobs/1957eb8da0a26e0c031aee76","canonicalUrl":"https://jobsearcher.com/jobs/1957eb8da0a26e0c031aee76","title":"Validation Engineer (Pharmaceutical)","description":"*CQV Specialist – Utilities | Pharmaceutical Manufacturing*\n\n*Location:* Juncos, Puerto Rico\n\nWe are seeking an experienced *CQV Specialist – Utilities* to support commissioning, qualification, validation, and maintenance activities within a *GMP-regulated pharmaceutical manufacturing environment* in Juncos, Puerto Rico.\n\nThe ideal candidate will have hands-on experience with *Commissioning, Qualification & Validation (CQV)* activities, GMP-regulated systems, validation protocols, technical documentation, investigations, and regulatory compliance.\n\nExperience supporting *non-critical utilities and utility system validation* is highly preferred.\n\nKey Responsibilities\n\n* Support *Commissioning, Qualification, and Validation (CQV)* activities for pharmaceutical manufacturing facilities and systems.\n* Develop, review, execute, and document qualification and validation activities in accordance with approved procedures and GMP requirements.\n* Support preparation and execution of *URS, Design Specifications (DS), IQ, OQ, and PQ protocols*.\n* Review engineering and design documentation to ensure systems are appropriately qualified and meet intended use requirements.\n* Support validation activities associated with *non-critical utilities and facility systems*.\n* Assist with commissioning activities, system start-up, testing, troubleshooting, and qualification.\n* Prepare and execute qualification protocols and associated test scripts.\n* Document test results, discrepancies, deviations, and qualification findings.\n* Support *deviation investigations, root-cause analysis, CAPA activities, and validation reports*.\n* Prepare and review technical documentation, reports, protocols, and other GMP records.\n* Ensure CQV documentation is complete, accurate, traceable, and compliant with applicable *cGMP and regulatory requirements*.\n* Work closely with Engineering, Facilities, Manufacturing, Quality, Validation, and other cross-functional teams.\n* Provide technical support during project execution and system qualification activities.\n* Participate in project meetings, design reviews, field activities, and technical investigations.\n* Ensure all activities are performed in accordance with approved procedures, regulatory requirements, and industry best practices.\n* Support maintenance and continued qualification activities as required.\n* Work extended hours, including *weekends and holidays*, when required by project schedules.\n\nRequired Qualifications\n\n* Bachelor's degree in *Engineering, Life Sciences, Chemistry, Biology, Pharmacy, or a related technical discipline* preferred.\n* Hands-on experience in *Commissioning, Qualification, Validation (CQV), equipment qualification, or pharmaceutical validation*.\n* Experience working in a *GMP/cGMP-regulated pharmaceutical, biotechnology, medical device, or other regulated manufacturing environment*.\n* Strong understanding of *cGMP/cGxP requirements and regulatory guidance*.\n* Hands-on experience developing and/or executing:\n* *URS – User Requirements Specifications*\n* *DS – Design Specifications*\n* *IQ – Installation Qualification*\n* *OQ – Operational Qualification*\n* *PQ – Performance Qualification*\n* Experience with *validation protocols, execution, documentation, and final reports*.\n* Experience with *deviations, investigations, discrepancies, and root-cause analysis*.\n* Strong *technical writing and documentation* skills.\n* Proficiency with *Microsoft Office and Windows-based applications*.\n* Ability to work effectively within a *multidisciplinary pharmaceutical project environment*.\n* *Fluent/bilingual in English and Spanish*, with strong verbal communication skills.\n\nPay: $34.91 - $45.89 per hour\n\nWork Location: In person","company":"Radiance Technologies","rawCompany":"radiance technologies","city":"Juncos","state":"PR","isRemote":false,"isActive":false,"createdAt":"2026-08-19T18:46:34.750Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"},{"code":"325411","title":"Medicinal and Botanical Manufacturing","slug":"medicinal-and-botanical-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Validation Engineer (Pharmaceutical)","description":"*CQV Specialist – Utilities | Pharmaceutical Manufacturing*\n\n*Location:* Juncos, Puerto Rico\n\nWe are seeking an experienced *CQV Specialist – Utilities* to support commissioning, qualification, validation, and maintenance activities within a *GMP-regulated pharmaceutical manufacturing environment* in Juncos, Puerto Rico.\n\nThe ideal candidate will have hands-on experience with *Commissioning, Qualification & Validation (CQV)* activities, GMP-regulated systems, validation protocols, technical documentation, investigations, and regulatory compliance.\n\nExperience supporting *non-critical utilities and utility system validation* is highly preferred.\n\nKey Responsibilities\n\n* Support *Commissioning, Qualification, and Validation (CQV)* activities for pharmaceutical manufacturing facilities and systems.\n* Develop, review, execute, and document qualification and validation activities in accordance with approved procedures and GMP requirements.\n* Support preparation and execution of *URS, Design Specifications (DS), IQ, OQ, and PQ protocols*.\n* Review engineering and design documentation to ensure systems are appropriately qualified and meet intended use requirements.\n* Support validation activities associated with *non-critical utilities and facility systems*.\n* Assist with commissioning activities, system start-up, testing, troubleshooting, and qualification.\n* Prepare and execute qualification protocols and associated test scripts.\n* Document test results, discrepancies, deviations, and qualification findings.\n* Support *deviation investigations, root-cause analysis, CAPA activities, and validation reports*.\n* Prepare and review technical documentation, reports, protocols, and other GMP records.\n* Ensure CQV documentation is complete, accurate, traceable, and compliant with applicable *cGMP and regulatory requirements*.\n* Work closely with Engineering, Facilities, Manufacturing, Quality, Validation, and other cross-functional teams.\n* Provide technical support during project execution and system qualification activities.\n* Participate in project meetings, design reviews, field activities, and technical investigations.\n* Ensure all activities are performed in accordance with approved procedures, regulatory requirements, and industry best practices.\n* Support maintenance and continued qualification activities as required.\n* Work extended hours, including *weekends and holidays*, when required by project schedules.\n\nRequired Qualifications\n\n* Bachelor's degree in *Engineering, Life Sciences, Chemistry, Biology, Pharmacy, or a related technical discipline* preferred.\n* Hands-on experience in *Commissioning, Qualification, Validation (CQV), equipment qualification, or pharmaceutical validation*.\n* Experience working in a *GMP/cGMP-regulated pharmaceutical, biotechnology, medical device, or other regulated manufacturing environment*.\n* Strong understanding of *cGMP/cGxP requirements and regulatory guidance*.\n* Hands-on experience developing and/or executing:\n* *URS – User Requirements Specifications*\n* *DS – Design Specifications*\n* *IQ – Installation Qualification*\n* *OQ – Operational Qualification*\n* *PQ – Performance Qualification*\n* Experience with *validation protocols, execution, documentation, and final reports*.\n* Experience with *deviations, investigations, discrepancies, and root-cause analysis*.\n* Strong *technical writing and documentation* skills.\n* Proficiency with *Microsoft Office and Windows-based applications*.\n* Ability to work effectively within a *multidisciplinary pharmaceutical project environment*.\n* *Fluent/bilingual in English and Spanish*, with strong verbal communication skills.\n\nPay: $34.91 - $45.89 per hour\n\nWork Location: In person","datePosted":"2026-08-19T18:46:34.750Z","dateModified":"2026-08-19T18:46:34.750Z","hiringOrganization":{"@type":"Organization","name":"Radiance Technologies","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Juncos","addressRegion":"PR","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"1957eb8da0a26e0c031aee76"},"url":"https://jobsearcher.com/jobs/1957eb8da0a26e0c031aee76"}}