{"schemaVersion":"jobsearcher.job.v1","id":"5e7bab3d04d67a9fa665c99f","url":"https://jobsearcher.com/jobs/5e7bab3d04d67a9fa665c99f","canonicalUrl":"https://jobsearcher.com/jobs/5e7bab3d04d67a9fa665c99f","title":"Sr. Engineer","description":"Summary\nWe are seeking a highly skilled and motivated Senior Engineer to support manufacturing operations within a regulated environment. This role will be responsible for providing technical leadership, supporting process improvements, leading investigations, and collaborating cross-functionally to ensure operational excellence, process robustness, and compliance with regulatory requirements.\nResponsibilities\nOwn change controls related to manufacturing process changes\nSupport major and trend deviation investigations throughout the full lifecycle\nConduct Root Cause Analysis investigations and determine Corrective and Preventive Actions (CAPA)\nAuthor technical investigation reports and support regulatory inspections\nSupport Risk Assessment exercises and microbial assessment evaluations\nLead commercial campaign readiness activities and collaborate effectively with cross-functional teams\nAssist in the development of training materials and provide technical/scientific process training\nProvide manufacturing support and troubleshooting on the production floor\nDesign, coordinate, and support execution of functional tests, water tests, and process challenge runs during major changes or campaign readiness\nGenerate technical protocols and related documentation as needed\nAssist and provide guidance during Master Batch Record (MBR) creation and revisions\nPerform assessments supporting process, automation, or equipment modifications and implementation of special projects\nInitiate, revise, and approve standard manufacturing procedures while ensuring procedures reflect current operations\nServe as document owner for manufacturing procedures\nAssess process performance and analyze operational data to identify and implement process improvement opportunities\nComplete CAPA applicability assessments for other plants/sites\nSupport assessments for new or revised Bills of Materials (BOMs)\nServe as a recognized technical specialist with responsibility for determining methodologies within assigned areas\nQualifications\nDoctorate Degree OR Master’s Degree + 2 years of Engineering experience\nOR Bachelor’s Degree in Engineering + 4 years of Engineering experience\nEducational background in Life Sciences and/or Engineering\nIn-depth experience in bioprocessing unit operations\nKnowledge of Root Cause Analysis methodologies including Fishbone, Six Boxes, 5 Why’s, Kepner-Tregoe\nFamiliarity with Lean Manufacturing practices\nAbility to communicate and collaborate effectively with technical and management teams across manufacturing, process development, and quality organizations\nProficiency in GDP (Good Documentation Practices) within regulated environments\nExperience using systems such as: Trackwise, Spotfire, CDOCS, Process monitoring platforms\nStrong technical writing and presentation skills\nExcellent verbal and written communication skills in both English and Spanish\nJob Type: Full-time\nPay: $45.00 - $50.00 per hour\nExperience:\nLean Manufacturing practices : 5 years (Preferred)\nGDP (Good Documentation Practices: 5 years (Preferred)\nTrackwise: 5 years (Preferred)\nSpotfire: 5 years (Preferred)\nCDOCS: 5 years (Preferred)\nProcess monitoring platforms : 5 years (Preferred)\ntechnical writing : 5 years (Preferred)\nbioprocessing unit operations : 5 years (Preferred)\nRoot Cause Analysis methodologies : 5 years (Preferred)\nFishbone: 5 years (Preferred)\nSix Boxes: 5 years (Preferred)\n5 Why’s: 5 years (Preferred)\nKepner-Tregoe : 5 years (Preferred)\nWork Location: In person","company":"Prpdg","rawCompany":"prpdg","city":"Juncos","state":"PR","isRemote":false,"isActive":false,"createdAt":"2026-08-03T13:15:35.827Z","occupations":[{"code":"17-2112.03","title":"Manufacturing Engineers","slug":"manufacturing-engineers"},{"code":"17-2199.00","title":"Engineers, All Other","slug":"engineers-all-other"},{"code":"17-2112.00","title":"Industrial Engineers","slug":"industrial-engineers"}],"industries":[{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"},{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Sr. Engineer","description":"Summary\nWe are seeking a highly skilled and motivated Senior Engineer to support manufacturing operations within a regulated environment. This role will be responsible for providing technical leadership, supporting process improvements, leading investigations, and collaborating cross-functionally to ensure operational excellence, process robustness, and compliance with regulatory requirements.\nResponsibilities\nOwn change controls related to manufacturing process changes\nSupport major and trend deviation investigations throughout the full lifecycle\nConduct Root Cause Analysis investigations and determine Corrective and Preventive Actions (CAPA)\nAuthor technical investigation reports and support regulatory inspections\nSupport Risk Assessment exercises and microbial assessment evaluations\nLead commercial campaign readiness activities and collaborate effectively with cross-functional teams\nAssist in the development of training materials and provide technical/scientific process training\nProvide manufacturing support and troubleshooting on the production floor\nDesign, coordinate, and support execution of functional tests, water tests, and process challenge runs during major changes or campaign readiness\nGenerate technical protocols and related documentation as needed\nAssist and provide guidance during Master Batch Record (MBR) creation and revisions\nPerform assessments supporting process, automation, or equipment modifications and implementation of special projects\nInitiate, revise, and approve standard manufacturing procedures while ensuring procedures reflect current operations\nServe as document owner for manufacturing procedures\nAssess process performance and analyze operational data to identify and implement process improvement opportunities\nComplete CAPA applicability assessments for other plants/sites\nSupport assessments for new or revised Bills of Materials (BOMs)\nServe as a recognized technical specialist with responsibility for determining methodologies within assigned areas\nQualifications\nDoctorate Degree OR Master’s Degree + 2 years of Engineering experience\nOR Bachelor’s Degree in Engineering + 4 years of Engineering experience\nEducational background in Life Sciences and/or Engineering\nIn-depth experience in bioprocessing unit operations\nKnowledge of Root Cause Analysis methodologies including Fishbone, Six Boxes, 5 Why’s, Kepner-Tregoe\nFamiliarity with Lean Manufacturing practices\nAbility to communicate and collaborate effectively with technical and management teams across manufacturing, process development, and quality organizations\nProficiency in GDP (Good Documentation Practices) within regulated environments\nExperience using systems such as: Trackwise, Spotfire, CDOCS, Process monitoring platforms\nStrong technical writing and presentation skills\nExcellent verbal and written communication skills in both English and Spanish\nJob Type: Full-time\nPay: $45.00 - $50.00 per hour\nExperience:\nLean Manufacturing practices : 5 years (Preferred)\nGDP (Good Documentation Practices: 5 years (Preferred)\nTrackwise: 5 years (Preferred)\nSpotfire: 5 years (Preferred)\nCDOCS: 5 years (Preferred)\nProcess monitoring platforms : 5 years (Preferred)\ntechnical writing : 5 years (Preferred)\nbioprocessing unit operations : 5 years (Preferred)\nRoot Cause Analysis methodologies : 5 years (Preferred)\nFishbone: 5 years (Preferred)\nSix Boxes: 5 years (Preferred)\n5 Why’s: 5 years (Preferred)\nKepner-Tregoe : 5 years (Preferred)\nWork Location: In person","datePosted":"2026-08-03T13:15:35.827Z","dateModified":"2026-08-03T13:15:35.827Z","hiringOrganization":{"@type":"Organization","name":"Prpdg","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Juncos","addressRegion":"PR","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"5e7bab3d04d67a9fa665c99f"},"url":"https://jobsearcher.com/jobs/5e7bab3d04d67a9fa665c99f"}}