{"schemaVersion":"jobsearcher.job.v1","id":"cc13227dbf84f4ad62cf8e1f","url":"https://jobsearcher.com/jobs/cc13227dbf84f4ad62cf8e1f","canonicalUrl":"https://jobsearcher.com/jobs/cc13227dbf84f4ad62cf8e1f","title":"Senior Engineer-35600","description":"Title: Senior Engineer (Job ID: 35600)\nLocation: Juncos, Puerto Rico\nImportant Notice: This opportunity is available only for direct individual candidates. Third-party contractor submissions, staffing vendors, and Corp-to-Corp (C2C) arrangements will not be considered for this position.\nWork Schedule: Onsite | Administrative Shift - Availability to work different Shifts and/ or weekend or business needs required\nPosition: 1\nContract Duration: 1 year\n\nPosition Summary\nOur client is seeking a Senior Engineer to independently lead and/or direct process optimization, troubleshooting, engineering assessments, and technical projects within operations, manufacturing, pilot plant, and capital project environments.\nThe position requires the application of advanced engineering principles to the design and implementation of major system modifications, experiments, process improvements, and capital projects. The Senior Engineer will develop, organize, analyze, and communicate technical results for operational issues and engineering projects involving significant scope and complexity.\n\nKey Responsibilities\nGeneral Engineering\nComplete complex or novel engineering assignments that require the development of new or improved engineering techniques, methods, and procedures.\nDevelop engineering policies and procedures that may impact multiple organizational units.\nSupervise, coordinate, and review the work of engineers, associates, and/or technicians on ongoing and project-based assignments.\nApply advanced engineering techniques and modify established approaches within the applicable area of engineering expertise.\nApply engineering principles and practices outside the primary discipline to a broad range of assignments in related technical fields.\nServe as a recognized engineering technology specialist in at least one area, with responsibility for determining appropriate methodologies and technical approaches.\nApply mature engineering knowledge to plan, execute, and manage engineering projects.\nIndependently evaluate technical challenges and determine appropriate methodologies, resources, and solutions.\n\nAdditional functions may be assigned as needed.\nDesign Engineering\nDevelop technical solutions to complex engineering problems requiring ingenuity, creativity, and sound engineering judgment.\nCollaborate with Research, Manufacturing, Process Development, Utilities, Facilities, Quality Assurance, and Validation teams to establish requirements and recommendations for large-scale or highly complex system and facility modifications.\nPartner with project managers to execute design and engineering projects within established schedule, budget, quality, and technical requirements.\nCoordinate consultants, architects, and engineering firms in the development and implementation of standard design documentation.\nDevelop departmental or project budgets involving multiple engineering disciplines or the full scope of smaller projects.\nProvide technical input and engineering recommendations throughout project planning, execution, and completion.\n\nEducation Requirements\nCandidates must meet one of the following educational requirements:\n\nDoctorate in Engineering or a related technical discipline; or\nMaster's degree in Engineering plus at least 2 years of engineering experience; or\nBachelor's degree in Engineering plus at least 4 years of engineering experience.\n\nRequired Knowledge and Skills\nWorking knowledge of pharmaceutical and/or biotechnology manufacturing processes.\nFamiliarity with equipment and process validation.\nExperience with technical documentation in highly regulated environments.\nAbility to operate specialized laboratory or manufacturing equipment and use relevant computer systems.\nAbility to interpret and apply GLP and GMP requirements.\nAbility to apply engineering principles and scientific knowledge to manufacturing and production environments.\nAbility to develop solutions to routine technical problems within defined scope.\nStrong problem-solving and applied engineering skills.\nBasic technical report-writing skills.\nStrong verbal and written communication skills.\nUnderstanding of validation protocol execution requirements.\nAbility to prepare and support validation protocols and related documentation.\nStrong organizational and time-management skills.\nAbility to adapt to changing priorities and manage multiple projects simultaneously.\nAbility to independently identify when additional internal or external resources are required to resolve technical issues.\nAbility to interact effectively with individuals across different communication and working styles.\nTechnical expertise with specialized equipment and processes.\nKnowledge of validation requirements associated with new equipment installations.\nAbility to apply analytical and scientific problem-solving techniques to develop hypotheses, evaluate alternatives, and determine appropriate engineering approaches.\nWorking knowledge of financial analysis and project cost-development tools.\nAbility to delegate responsibilities and effectively manage the project work of others.\n\nProject Management and Leadership Skills\nDemonstrated ability in:\nSchedule development and project coordination.\nFacilitation and cross-functional collaboration.\nBasic project management.\nProject completion, follow-up, and deliverable tracking.\nNegotiation and persuasion.\nConflict resolution.\nLeadership and team building.\nProject cost development and budget management.\nManaging multiple technical projects and priorities simultaneously.\nProviding solutions to technical problems of moderate to significant complexity and scope.\nApplying engineering theory, scientific principles, calculations, and creative problem-solving techniques to complex technical challenges.\nEstablishing engineering expertise in at least three separate areas of engineering technology.\n\nPreferred Experience — Technical Assessments\nThe preferred candidate will have experience performing technical assessments of equipment in regulated pharmaceutical or biotechnology manufacturing environments.\n\nExperience should include:\nPreparing, reviewing, and approving technical reports, engineering assessments, equipment evaluations, and technical justifications.\nEvaluating equipment failures, performance issues, maintenance history, operating conditions, and potential impacts to products, processes, quality, and the qualified state of equipment.\nProviding technical support for deviations, investigations, CAPAs, change controls, risk assessments, and post-FDA commitments.\nAssessing equipment design, functionality, reliability, lifecycle documentation, maintenance strategies, and continued fitness for intended use.\nReviewing and interpreting engineering drawings, technical specifications, vendor documentation, equipment manuals, work orders, calibration records, and historical performance data.\nDeveloping clear, factual, and scientifically supported conclusions and recommendations based on available technical evidence.\nCollaborating with Manufacturing, Maintenance, Automation, Validation, Quality, Process Development, and external vendors to obtain, evaluate, and validate technical information.\nApplying cGMP requirements to ensure technical assessments are complete, traceable, inspection-ready, and supported by objective evidence.\nPreparing clear technical documentation and communicating findings and recommendations to cross-functional stakeholders.\nIndependently managing multiple technical assessments, investigations, and deliverables while maintaining established timelines and quality standards.\nProviding technical expertise related to purification, fermentation, process equipment, utilities, and/or pharmaceutical manufacturing systems is preferred.\nMaintaining a strong field presence within manufacturing areas, including inspecting equipment and verifying actual operating conditions.\nEvaluating equipment condition and operating performance using available technical documentation, historical data, maintenance records, and direct field observations.","company":"Proqualitynetwork","rawCompany":"proqualitynetwork","city":"Juncos","state":"PR","isRemote":false,"isActive":false,"createdAt":"2026-08-12T13:52:02.876Z","occupations":[{"code":"17-2199.00","title":"Engineers, All Other","slug":"engineers-all-other"},{"code":"11-9041.00","title":"Architectural and Engineering Managers","slug":"architectural-and-engineering-managers"},{"code":"17-2112.03","title":"Manufacturing Engineers","slug":"manufacturing-engineers"}],"industries":[{"code":"541330","title":"Engineering Services","slug":"engineering-services"},{"code":"541715","title":"Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)","slug":"research-and-development-in-the-physical-engineering-and-life-sciences-except-nanotechnology-and-biotechnology"},{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Senior Engineer-35600","description":"Title: Senior Engineer (Job ID: 35600)\nLocation: Juncos, Puerto Rico\nImportant Notice: This opportunity is available only for direct individual candidates. Third-party contractor submissions, staffing vendors, and Corp-to-Corp (C2C) arrangements will not be considered for this position.\nWork Schedule: Onsite | Administrative Shift - Availability to work different Shifts and/ or weekend or business needs required\nPosition: 1\nContract Duration: 1 year\n\nPosition Summary\nOur client is seeking a Senior Engineer to independently lead and/or direct process optimization, troubleshooting, engineering assessments, and technical projects within operations, manufacturing, pilot plant, and capital project environments.\nThe position requires the application of advanced engineering principles to the design and implementation of major system modifications, experiments, process improvements, and capital projects. The Senior Engineer will develop, organize, analyze, and communicate technical results for operational issues and engineering projects involving significant scope and complexity.\n\nKey Responsibilities\nGeneral Engineering\nComplete complex or novel engineering assignments that require the development of new or improved engineering techniques, methods, and procedures.\nDevelop engineering policies and procedures that may impact multiple organizational units.\nSupervise, coordinate, and review the work of engineers, associates, and/or technicians on ongoing and project-based assignments.\nApply advanced engineering techniques and modify established approaches within the applicable area of engineering expertise.\nApply engineering principles and practices outside the primary discipline to a broad range of assignments in related technical fields.\nServe as a recognized engineering technology specialist in at least one area, with responsibility for determining appropriate methodologies and technical approaches.\nApply mature engineering knowledge to plan, execute, and manage engineering projects.\nIndependently evaluate technical challenges and determine appropriate methodologies, resources, and solutions.\n\nAdditional functions may be assigned as needed.\nDesign Engineering\nDevelop technical solutions to complex engineering problems requiring ingenuity, creativity, and sound engineering judgment.\nCollaborate with Research, Manufacturing, Process Development, Utilities, Facilities, Quality Assurance, and Validation teams to establish requirements and recommendations for large-scale or highly complex system and facility modifications.\nPartner with project managers to execute design and engineering projects within established schedule, budget, quality, and technical requirements.\nCoordinate consultants, architects, and engineering firms in the development and implementation of standard design documentation.\nDevelop departmental or project budgets involving multiple engineering disciplines or the full scope of smaller projects.\nProvide technical input and engineering recommendations throughout project planning, execution, and completion.\n\nEducation Requirements\nCandidates must meet one of the following educational requirements:\n\nDoctorate in Engineering or a related technical discipline; or\nMaster's degree in Engineering plus at least 2 years of engineering experience; or\nBachelor's degree in Engineering plus at least 4 years of engineering experience.\n\nRequired Knowledge and Skills\nWorking knowledge of pharmaceutical and/or biotechnology manufacturing processes.\nFamiliarity with equipment and process validation.\nExperience with technical documentation in highly regulated environments.\nAbility to operate specialized laboratory or manufacturing equipment and use relevant computer systems.\nAbility to interpret and apply GLP and GMP requirements.\nAbility to apply engineering principles and scientific knowledge to manufacturing and production environments.\nAbility to develop solutions to routine technical problems within defined scope.\nStrong problem-solving and applied engineering skills.\nBasic technical report-writing skills.\nStrong verbal and written communication skills.\nUnderstanding of validation protocol execution requirements.\nAbility to prepare and support validation protocols and related documentation.\nStrong organizational and time-management skills.\nAbility to adapt to changing priorities and manage multiple projects simultaneously.\nAbility to independently identify when additional internal or external resources are required to resolve technical issues.\nAbility to interact effectively with individuals across different communication and working styles.\nTechnical expertise with specialized equipment and processes.\nKnowledge of validation requirements associated with new equipment installations.\nAbility to apply analytical and scientific problem-solving techniques to develop hypotheses, evaluate alternatives, and determine appropriate engineering approaches.\nWorking knowledge of financial analysis and project cost-development tools.\nAbility to delegate responsibilities and effectively manage the project work of others.\n\nProject Management and Leadership Skills\nDemonstrated ability in:\nSchedule development and project coordination.\nFacilitation and cross-functional collaboration.\nBasic project management.\nProject completion, follow-up, and deliverable tracking.\nNegotiation and persuasion.\nConflict resolution.\nLeadership and team building.\nProject cost development and budget management.\nManaging multiple technical projects and priorities simultaneously.\nProviding solutions to technical problems of moderate to significant complexity and scope.\nApplying engineering theory, scientific principles, calculations, and creative problem-solving techniques to complex technical challenges.\nEstablishing engineering expertise in at least three separate areas of engineering technology.\n\nPreferred Experience — Technical Assessments\nThe preferred candidate will have experience performing technical assessments of equipment in regulated pharmaceutical or biotechnology manufacturing environments.\n\nExperience should include:\nPreparing, reviewing, and approving technical reports, engineering assessments, equipment evaluations, and technical justifications.\nEvaluating equipment failures, performance issues, maintenance history, operating conditions, and potential impacts to products, processes, quality, and the qualified state of equipment.\nProviding technical support for deviations, investigations, CAPAs, change controls, risk assessments, and post-FDA commitments.\nAssessing equipment design, functionality, reliability, lifecycle documentation, maintenance strategies, and continued fitness for intended use.\nReviewing and interpreting engineering drawings, technical specifications, vendor documentation, equipment manuals, work orders, calibration records, and historical performance data.\nDeveloping clear, factual, and scientifically supported conclusions and recommendations based on available technical evidence.\nCollaborating with Manufacturing, Maintenance, Automation, Validation, Quality, Process Development, and external vendors to obtain, evaluate, and validate technical information.\nApplying cGMP requirements to ensure technical assessments are complete, traceable, inspection-ready, and supported by objective evidence.\nPreparing clear technical documentation and communicating findings and recommendations to cross-functional stakeholders.\nIndependently managing multiple technical assessments, investigations, and deliverables while maintaining established timelines and quality standards.\nProviding technical expertise related to purification, fermentation, process equipment, utilities, and/or pharmaceutical manufacturing systems is preferred.\nMaintaining a strong field presence within manufacturing areas, including inspecting equipment and verifying actual operating conditions.\nEvaluating equipment condition and operating performance using available technical documentation, historical data, maintenance records, and direct field observations.","datePosted":"2026-08-12T13:52:02.876Z","dateModified":"2026-08-12T13:52:02.876Z","hiringOrganization":{"@type":"Organization","name":"Proqualitynetwork","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Juncos","addressRegion":"PR","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"cc13227dbf84f4ad62cf8e1f"},"url":"https://jobsearcher.com/jobs/cc13227dbf84f4ad62cf8e1f"}}