{"schemaVersion":"jobsearcher.job.v1","id":"ec5a19152fbe40e1c142595d","url":"https://jobsearcher.com/jobs/ec5a19152fbe40e1c142595d","canonicalUrl":"https://jobsearcher.com/jobs/ec5a19152fbe40e1c142595d","title":"Process Engineer","description":"Role Overview:Seeking an experienced Process Engineer to support end-to-end manufacturing operations in an FDA-regulated biologics/aseptic environment, with strong focus on troubleshooting, process optimization, and validation support.Key Responsibilities:Provide hands-on engineering support across production processes and resolve equipment/process issues in real time with operations teams.Lead investigations, root cause analysis, deviations, and corrective/preventive actions to improve process stability and performance.Support validation activities including IQ/OQ/PQ, continued process verification (CPV), change control, and process monitoring.Collaborate with QA, QC, Maintenance, and Operations to ensure robust, compliant, and efficient manufacturing processes.Support line trials, startup/ramp-up activities, and process improvements focused on yield, quality, throughput, and waste reduction.Assist Project Engineering from URS development through FAT/SAT and installation/qualification activities.Required Experience & Skills:7–10+ years of process engineering experience in FDA-regulated or controlled manufacturing environments.Strong expertise in biologics/aseptic processing and troubleshooting in live production settings.Hands-on experience with deviations, investigations, RCA, change control, and process improvement.Working knowledge of validation lifecycle and project engineering principles.Ability to work full-time on-site in a manufacturing environment with direct operator interaction.Bachelor’s degree in Chemical, Mechanical, Industrial, or related Engineering discipline.Preferred Experience:Exposure to startup, tech transfer, or new product introduction.Familiarity with Lean, TPM, FMEA, CPV, and reliability improvement methodologies.Experience with SAP, MES, or Power BI systems.","company":"Intellectt","rawCompany":"intellectt","city":"Omaha","state":"NE","isRemote":false,"isActive":false,"createdAt":"2026-06-02T02:40:07.719Z","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":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"},{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"},{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Process Engineer","description":"Role Overview:Seeking an experienced Process Engineer to support end-to-end manufacturing operations in an FDA-regulated biologics/aseptic environment, with strong focus on troubleshooting, process optimization, and validation support.Key Responsibilities:Provide hands-on engineering support across production processes and resolve equipment/process issues in real time with operations teams.Lead investigations, root cause analysis, deviations, and corrective/preventive actions to improve process stability and performance.Support validation activities including IQ/OQ/PQ, continued process verification (CPV), change control, and process monitoring.Collaborate with QA, QC, Maintenance, and Operations to ensure robust, compliant, and efficient manufacturing processes.Support line trials, startup/ramp-up activities, and process improvements focused on yield, quality, throughput, and waste reduction.Assist Project Engineering from URS development through FAT/SAT and installation/qualification activities.Required Experience & Skills:7–10+ years of process engineering experience in FDA-regulated or controlled manufacturing environments.Strong expertise in biologics/aseptic processing and troubleshooting in live production settings.Hands-on experience with deviations, investigations, RCA, change control, and process improvement.Working knowledge of validation lifecycle and project engineering principles.Ability to work full-time on-site in a manufacturing environment with direct operator interaction.Bachelor’s degree in Chemical, Mechanical, Industrial, or related Engineering discipline.Preferred Experience:Exposure to startup, tech transfer, or new product introduction.Familiarity with Lean, TPM, FMEA, CPV, and reliability improvement methodologies.Experience with SAP, MES, or Power BI systems.","datePosted":"2026-06-02T02:40:07.719Z","dateModified":"2026-06-02T02:40:07.719Z","hiringOrganization":{"@type":"Organization","name":"Intellectt","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Omaha","addressRegion":"NE","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"ec5a19152fbe40e1c142595d"},"url":"https://jobsearcher.com/jobs/ec5a19152fbe40e1c142595d"}}