{"schemaVersion":"jobsearcher.job.v1","id":"a2aed8fe2bd5c7c500a82e7a","url":"https://jobsearcher.com/jobs/a2aed8fe2bd5c7c500a82e7a","canonicalUrl":"https://jobsearcher.com/jobs/a2aed8fe2bd5c7c500a82e7a","title":"Process Engineer","description":"Position Summary:\nClient is seeking an experienced and driven Process Engineer to support key functions for radiopharmaceutical manufacturing which includes product support, process support, process engineering, equipment/utility engineering, maintenance programs, and technical troubleshooting in support of automated manufacturing lines. The individual brings hands-on experience in cGMP manufacturing support, with a strong understanding of sterile drug production, radiopharmaceutical workflows, and medical device quality systems.\nKey Responsibilities:\nProvide day-to-day technical support to manufacturing operations, ensuring reliable production.\nLead investigations for moderate- to high-complexity deviations, perform root cause analyses, and implement CAPAs in collaboration with QA and operations teams.\nAuthor and revise controlled documents, including manufacturing documentation, technical reports, protocols (e.g., process validation, equipment qualification), and risk assessments.\nSupport process monitoring, trending, and data analysis activities to drive continuous improvement and maintain a state of control.\nParticipate in cross-functional teams for process changes, equipment upgrades, and lifecycle projects, ensuring alignment with regulatory and quality requirements.\nAct as a technical contributor in change control execution, including impact assessments, protocol generation, and implementation planning.\nSupport and/or lead multiple technical transfers, scale-ups, and process validation activities.\nCollaborate with stakeholders in Manufacturing, QA, QC, Engineering, and Supply Chain to ensure timely and compliant execution of manufacturing campaigns.\nEnsure compliance with applicable regulations, including 21 CFR Parts 210, 211, 820, EU GMP Annex 1, and radiation safety requirements.\nSupport readiness activities for internal and regulatory audits, including documentation review and SME participation.\nQualifications:\nBachelor’s degree in Chemical Engineering, Mechanical Engineering, Nuclear Engineering, Chemistry, or a related technical field (advanced degree preferred).\n6+ years of experience in medical device manufacturing, with a strong focus on sterile injectable or radiopharmaceutical production. is a plus.\nSolid understanding of cGMPs, aseptic processing, cleanroom operations, and medical device/combination product regulations (21 CFR 210, 21 CFR 211, 21 CFR 820, ISO 13485).\nDemonstrated ability to investigate deviations, problem solve, and execute changes within a quality system framework. Advanced technical writing skills required.\nHands-on experience with equipment commonly used in sterile fill/finish operations.\nDemonstrated ability to lead process validation, equipment qualification, and risk management effor\nSelf-starter with strong interpersonal and communication skills; able to work independently and in cross-functional teams.\nProficiency in Excel, data analysis tools, and electronic document/change control systems (e.g., TrackWise, CATSWeb). Skilled at presenting technical content to technical and non-technical audiences.\nPreferred Experience:\nExpereince with lean manufacturing principles and driving process improvements in any scale.\nExperience in lifecycle management of commercially approved pharmaceutical products and devices.\nExperience in managing large cross-functional projects in a matrix environment.\n\nPay range $40-$50/hr\n\n#LI-JD1\nATG456","company":"Alexander Technology Group","rawCompany":"alexander technology group","city":"North Billerica","state":"MA","isRemote":false,"isActive":false,"createdAt":"2026-08-22T11:30:41.040Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"17-2112.03","title":"Manufacturing Engineers","slug":"manufacturing-engineers"},{"code":"17-2041.00","title":"Chemical Engineers","slug":"chemical-engineers"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"},{"code":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Process Engineer","description":"Position Summary:\nClient is seeking an experienced and driven Process Engineer to support key functions for radiopharmaceutical manufacturing which includes product support, process support, process engineering, equipment/utility engineering, maintenance programs, and technical troubleshooting in support of automated manufacturing lines. The individual brings hands-on experience in cGMP manufacturing support, with a strong understanding of sterile drug production, radiopharmaceutical workflows, and medical device quality systems.\nKey Responsibilities:\nProvide day-to-day technical support to manufacturing operations, ensuring reliable production.\nLead investigations for moderate- to high-complexity deviations, perform root cause analyses, and implement CAPAs in collaboration with QA and operations teams.\nAuthor and revise controlled documents, including manufacturing documentation, technical reports, protocols (e.g., process validation, equipment qualification), and risk assessments.\nSupport process monitoring, trending, and data analysis activities to drive continuous improvement and maintain a state of control.\nParticipate in cross-functional teams for process changes, equipment upgrades, and lifecycle projects, ensuring alignment with regulatory and quality requirements.\nAct as a technical contributor in change control execution, including impact assessments, protocol generation, and implementation planning.\nSupport and/or lead multiple technical transfers, scale-ups, and process validation activities.\nCollaborate with stakeholders in Manufacturing, QA, QC, Engineering, and Supply Chain to ensure timely and compliant execution of manufacturing campaigns.\nEnsure compliance with applicable regulations, including 21 CFR Parts 210, 211, 820, EU GMP Annex 1, and radiation safety requirements.\nSupport readiness activities for internal and regulatory audits, including documentation review and SME participation.\nQualifications:\nBachelor’s degree in Chemical Engineering, Mechanical Engineering, Nuclear Engineering, Chemistry, or a related technical field (advanced degree preferred).\n6+ years of experience in medical device manufacturing, with a strong focus on sterile injectable or radiopharmaceutical production. is a plus.\nSolid understanding of cGMPs, aseptic processing, cleanroom operations, and medical device/combination product regulations (21 CFR 210, 21 CFR 211, 21 CFR 820, ISO 13485).\nDemonstrated ability to investigate deviations, problem solve, and execute changes within a quality system framework. Advanced technical writing skills required.\nHands-on experience with equipment commonly used in sterile fill/finish operations.\nDemonstrated ability to lead process validation, equipment qualification, and risk management effor\nSelf-starter with strong interpersonal and communication skills; able to work independently and in cross-functional teams.\nProficiency in Excel, data analysis tools, and electronic document/change control systems (e.g., TrackWise, CATSWeb). Skilled at presenting technical content to technical and non-technical audiences.\nPreferred Experience:\nExpereince with lean manufacturing principles and driving process improvements in any scale.\nExperience in lifecycle management of commercially approved pharmaceutical products and devices.\nExperience in managing large cross-functional projects in a matrix environment.\n\nPay range $40-$50/hr\n\n#LI-JD1\nATG456","datePosted":"2026-08-22T11:30:41.040Z","dateModified":"2026-08-22T11:30:41.040Z","hiringOrganization":{"@type":"Organization","name":"Alexander Technology Group","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"North Billerica","addressRegion":"MA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"a2aed8fe2bd5c7c500a82e7a"},"url":"https://jobsearcher.com/jobs/a2aed8fe2bd5c7c500a82e7a"}}