{"schemaVersion":"jobsearcher.job.v1","id":"ea4fa1ecfaf3254c2fd2869c","url":"https://jobsearcher.com/jobs/ea4fa1ecfaf3254c2fd2869c","canonicalUrl":"https://jobsearcher.com/jobs/ea4fa1ecfaf3254c2fd2869c","title":"Process Development Engineer","description":"mîrus Consulting Group is a Puerto Rico based technical services firm headquartered in Humacao. The company specializes in Computer System Validation (CSV) and Information Technology consulting for the pharmaceutical and life sciences industries across Puerto Rico and parts of the United States. Its services include the assessment and validation of automation systems, network infrastructures, and business processes, as well as comprehensive project management support to ensure compliance, efficiency, and operational excellence.\n\nRole Summary\nThe Process Development Engineer supports the development, validation, and implementation of new manufacturing processes. The role involves equipment and process validation, documentation generation, process optimization, and cross-functional technical collaboration.\n\nKey Responsibilities\nSupport IQ/OQ/PQ and process performance qualification activities; develop validation protocols, reports, and master validation plans.\nDesign and develop in‑process and receiving inspection systems for new components and processes.\nGenerate equipment documentation (evaluations, PM/calibration procedures) and manufacturing instructions.\nManage process development projects from concept through implementation, collaborating with cross-functional teams.\nApply DOE, PFMEA, and risk analysis to characterize, optimize, and improve manufacturing processes.\nWork with technologies such as laser welding, heat bonding, injection molding, vision systems, and automation (PLC/servo/pneumatics/sensors).\nExperience Requirements\n5–7+ years in manufacturing engineering or quality engineering within an FDA‑regulated environment (medical devices, pharma, diagnostics, biotech).\nStrong working knowledge of 21 CFR Part 820, GMP, and ISO 13485.\nElectrical and mechanical engineering background applied to automated manufacturing systems.\nExperience with automation/controls, tooling, fixtures, test method development, and equipment qualification.\nProficiency in DOE, FMEA, CAPA, and root‑cause investigation.\nExperience supporting new product introductions and process scale‑up.\nThis Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.","company":"Mirus Consulting Group","rawCompany":"mirus consulting group","city":"Dorado","state":"PR","isRemote":false,"isActive":false,"createdAt":"2026-04-14T11:11:47.842Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"17-2112.03","title":"Manufacturing Engineers","slug":"manufacturing-engineers"},{"code":"17-2112.00","title":"Industrial Engineers","slug":"industrial-engineers"}],"industries":[{"code":"541690","title":"Other Scientific and Technical Consulting Services","slug":"other-scientific-and-technical-consulting-services"},{"code":"541330","title":"Engineering Services","slug":"engineering-services"},{"code":"541614","title":"Process, Physical Distribution, and Logistics Consulting Services","slug":"process-physical-distribution-and-logistics-consulting-services"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Process Development Engineer","description":"mîrus Consulting Group is a Puerto Rico based technical services firm headquartered in Humacao. The company specializes in Computer System Validation (CSV) and Information Technology consulting for the pharmaceutical and life sciences industries across Puerto Rico and parts of the United States. Its services include the assessment and validation of automation systems, network infrastructures, and business processes, as well as comprehensive project management support to ensure compliance, efficiency, and operational excellence.\n\nRole Summary\nThe Process Development Engineer supports the development, validation, and implementation of new manufacturing processes. The role involves equipment and process validation, documentation generation, process optimization, and cross-functional technical collaboration.\n\nKey Responsibilities\nSupport IQ/OQ/PQ and process performance qualification activities; develop validation protocols, reports, and master validation plans.\nDesign and develop in‑process and receiving inspection systems for new components and processes.\nGenerate equipment documentation (evaluations, PM/calibration procedures) and manufacturing instructions.\nManage process development projects from concept through implementation, collaborating with cross-functional teams.\nApply DOE, PFMEA, and risk analysis to characterize, optimize, and improve manufacturing processes.\nWork with technologies such as laser welding, heat bonding, injection molding, vision systems, and automation (PLC/servo/pneumatics/sensors).\nExperience Requirements\n5–7+ years in manufacturing engineering or quality engineering within an FDA‑regulated environment (medical devices, pharma, diagnostics, biotech).\nStrong working knowledge of 21 CFR Part 820, GMP, and ISO 13485.\nElectrical and mechanical engineering background applied to automated manufacturing systems.\nExperience with automation/controls, tooling, fixtures, test method development, and equipment qualification.\nProficiency in DOE, FMEA, CAPA, and root‑cause investigation.\nExperience supporting new product introductions and process scale‑up.\nThis Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.","datePosted":"2026-04-14T11:11:47.842Z","dateModified":"2026-04-14T11:11:47.842Z","hiringOrganization":{"@type":"Organization","name":"Mirus Consulting Group","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Dorado","addressRegion":"PR","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"ea4fa1ecfaf3254c2fd2869c"},"url":"https://jobsearcher.com/jobs/ea4fa1ecfaf3254c2fd2869c"}}