{"schemaVersion":"jobsearcher.job.v1","id":"522d74fda453cb17c526115e","url":"https://jobsearcher.com/jobs/522d74fda453cb17c526115e","canonicalUrl":"https://jobsearcher.com/jobs/522d74fda453cb17c526115e","title":"Senior Engineer - Juncos, PR","description":"1. C&Q Strategy & Planning\n\n* Develop and implement the overall Commissioning & Qualification strategy aligned with project and regulatory requirements.\n* Define system boundaries and identify direct/indirect impact systems.\n* Lead risk assessments (e.g., ISPE Baseline, ASTM E2500) to determine qualification scope.\n* Develop C&Q plans, schedules, and resource forecasting.\n\n2. Commissioning Activities\n\n* *Oversee and/or execute commissioning activities including FAT, SAT, and field commissioning.*\n* *Ensure systems are installed and operate per design specifications.*\n* Coordinate with vendors and contractors during startup activities.\n* Review and approve commissioning documentation and test results.\n\n3. Qualification Execution (IQ/OQ/PQ)\n\n4. Documentation & Compliance\n\n5. Risk Management & Change Control\n\n6. Cross-functional Coordination\n\n7. Characterization Process\n\n* Author, review, and approve qualification protocols (IQ, OQ, PQ).\n* Ensure traceability from User Requirements Specifications (URS) through testing.\n* Execute or oversee protocol execution and ensure proper documentation of results.\n* Ensure all C&Q documentation complies with GMP, FDA, EMA, and internal Amgen standards.\n* Maintain document lifecycle within electronic systems.\n* Support data integrity and ALCOA+ principles throughout qualification activities.\n* Prepare and support validation summary reports.\n* Lead and document risk assessments related to system qualification.\n* Evaluate and manage change controls impacting validated systems.\n* Assess impact of deviations and implement corrective and preventive actions (CAPA).\n* Collaborate with Engineering, Validation, Quality Assurance (QA), Manufacturing, and Supply Chain teams.\n* Interface with system owners and technical authorities.\n* Provide technical guidance and mentorship to junior engineers and project team members.\n* Support project meetings, status reporting, and stakeholder communication.\n* Develop the characterization protocols.\n* Execute the characterization activities.\n* Develop and review the characterization reports\n* Doctorate OR -Masters + 2 years of Engineering experience OR\n* Bachelors in Engineering + 4 years of Engineering experience.\n\nPay: $40.00 - $55.00 per hour\n\nWork Location: In person","company":"Ispv","rawCompany":"ispv","city":"Juncos","state":"PR","isRemote":false,"isActive":false,"createdAt":"2026-09-04T10:33:30.503Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"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"}],"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":"237990","title":"Other Heavy and Civil Engineering Construction","slug":"other-heavy-and-civil-engineering-construction"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Senior Engineer - Juncos, PR","description":"1. C&Q Strategy & Planning\n\n* Develop and implement the overall Commissioning & Qualification strategy aligned with project and regulatory requirements.\n* Define system boundaries and identify direct/indirect impact systems.\n* Lead risk assessments (e.g., ISPE Baseline, ASTM E2500) to determine qualification scope.\n* Develop C&Q plans, schedules, and resource forecasting.\n\n2. Commissioning Activities\n\n* *Oversee and/or execute commissioning activities including FAT, SAT, and field commissioning.*\n* *Ensure systems are installed and operate per design specifications.*\n* Coordinate with vendors and contractors during startup activities.\n* Review and approve commissioning documentation and test results.\n\n3. Qualification Execution (IQ/OQ/PQ)\n\n4. Documentation & Compliance\n\n5. Risk Management & Change Control\n\n6. Cross-functional Coordination\n\n7. Characterization Process\n\n* Author, review, and approve qualification protocols (IQ, OQ, PQ).\n* Ensure traceability from User Requirements Specifications (URS) through testing.\n* Execute or oversee protocol execution and ensure proper documentation of results.\n* Ensure all C&Q documentation complies with GMP, FDA, EMA, and internal Amgen standards.\n* Maintain document lifecycle within electronic systems.\n* Support data integrity and ALCOA+ principles throughout qualification activities.\n* Prepare and support validation summary reports.\n* Lead and document risk assessments related to system qualification.\n* Evaluate and manage change controls impacting validated systems.\n* Assess impact of deviations and implement corrective and preventive actions (CAPA).\n* Collaborate with Engineering, Validation, Quality Assurance (QA), Manufacturing, and Supply Chain teams.\n* Interface with system owners and technical authorities.\n* Provide technical guidance and mentorship to junior engineers and project team members.\n* Support project meetings, status reporting, and stakeholder communication.\n* Develop the characterization protocols.\n* Execute the characterization activities.\n* Develop and review the characterization reports\n* Doctorate OR -Masters + 2 years of Engineering experience OR\n* Bachelors in Engineering + 4 years of Engineering experience.\n\nPay: $40.00 - $55.00 per hour\n\nWork Location: In person","datePosted":"2026-09-04T10:33:30.503Z","dateModified":"2026-09-04T10:33:30.503Z","hiringOrganization":{"@type":"Organization","name":"Ispv","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Juncos","addressRegion":"PR","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"522d74fda453cb17c526115e"},"url":"https://jobsearcher.com/jobs/522d74fda453cb17c526115e"}}