{"schemaVersion":"jobsearcher.job.v1","id":"648aecf6f6349303cbf9b502","url":"https://jobsearcher.com/jobs/648aecf6f6349303cbf9b502","canonicalUrl":"https://jobsearcher.com/jobs/648aecf6f6349303cbf9b502","title":"Senior Process Engineer","description":"🚀 Senior Process / Equipment Engineer (Drug Substance) – 2-Year Capital Project 📍 North Carolina (Onsite) 🏭 Biologics Manufacturing ExpansionTechnical Source is supporting a leading pharmaceutical manufacturing client as they expand their drug substance (DS) manufacturing capabilities at a North Carolina site.We are looking for a Senior Process / Equipment Engineer to join the Process Systems / Utilities Engineering team and take ownership of critical upstream and downstream systems from design through startup on a large-scale biologics program.🔬 Project OverviewThis is a major capital expansion featuring:Five 10,000L stainless steel bioreactorsOne full downstream purification trainThe project is currently in the design phase, giving you the opportunity to: ➡️ Influence system design early ➡️ Own your equipment through installation, commissioning, qualification, and startup🎯 What You’ll Be DoingYou will act as the equipment engineering lead for key process systems, including:Bioreactors (up to 10,000L)TFF (tangential flow filtration) skidsChromatography systemsViral / depth filtration systemsStainless steel tank skids (media, buffer, hold)Key Responsibilities:Lead design reviews (P&IDs, GA drawings, specs)Ensure compliance with ASME BPE + hygienic design standardsTranslate process requirements into DeltaV automation strategyPartner with Automation on:Control strategiesInterlocks + alarmsBatch/recipe executionDrive systems through:Mechanical Completion (MC)Commissioning & Qualification (C&Q)StartupYou’ll also:Support field installation + walkdownsTroubleshoot during C&Q + startupCoordinate across Engineering, Automation, CQV, Manufacturing, and Quality🧠 What We’re Looking ForMust-Have Experience:Leading design + installation of:TFF, Chromatography, Filtration, or Tank SystemsHands-on involvement in:Commissioning + IQ/OQ (PQ a plus)Strong understanding of:Drug substance (DS) processes (upstream/downstream)Experience working with:DeltaV environments (functional collaboration level)Knowledge of:ASME BPE / hygienic piping / fabrication standards💡 Nice to HaveBiologics experience (mAbs, recombinant proteins)Large-scale capital or greenfield projectsVendor management (FAT/SAT)Risk-based CQV (ASTM E2500)⚙️ The Role100% Onsite – North Carolina2-Year ContractHighly visible role on a flagship biologics expansion🔥 Why This Role Stands OutOwn systems end-to-end (design → startup)Work on large-scale biologics manufacturingHigh-impact role with cross-functional leadership exposureBe part of a major U.S. pharma expansion program📩 If you’ve been through design, build, and startup of DS systems and want to be part of something big — let’s connect.","company":"Technical Source","rawCompany":"technical source","city":"Raleigh","state":"NC","isRemote":false,"isActive":false,"createdAt":"2026-04-29T02:49:45.548Z","occupations":[{"code":"17-2041.00","title":"Chemical Engineers","slug":"chemical-engineers"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"17-2199.00","title":"Engineers, All Other","slug":"engineers-all-other"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"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"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Senior Process Engineer","description":"🚀 Senior Process / Equipment Engineer (Drug Substance) – 2-Year Capital Project 📍 North Carolina (Onsite) 🏭 Biologics Manufacturing ExpansionTechnical Source is supporting a leading pharmaceutical manufacturing client as they expand their drug substance (DS) manufacturing capabilities at a North Carolina site.We are looking for a Senior Process / Equipment Engineer to join the Process Systems / Utilities Engineering team and take ownership of critical upstream and downstream systems from design through startup on a large-scale biologics program.🔬 Project OverviewThis is a major capital expansion featuring:Five 10,000L stainless steel bioreactorsOne full downstream purification trainThe project is currently in the design phase, giving you the opportunity to: ➡️ Influence system design early ➡️ Own your equipment through installation, commissioning, qualification, and startup🎯 What You’ll Be DoingYou will act as the equipment engineering lead for key process systems, including:Bioreactors (up to 10,000L)TFF (tangential flow filtration) skidsChromatography systemsViral / depth filtration systemsStainless steel tank skids (media, buffer, hold)Key Responsibilities:Lead design reviews (P&IDs, GA drawings, specs)Ensure compliance with ASME BPE + hygienic design standardsTranslate process requirements into DeltaV automation strategyPartner with Automation on:Control strategiesInterlocks + alarmsBatch/recipe executionDrive systems through:Mechanical Completion (MC)Commissioning & Qualification (C&Q)StartupYou’ll also:Support field installation + walkdownsTroubleshoot during C&Q + startupCoordinate across Engineering, Automation, CQV, Manufacturing, and Quality🧠 What We’re Looking ForMust-Have Experience:Leading design + installation of:TFF, Chromatography, Filtration, or Tank SystemsHands-on involvement in:Commissioning + IQ/OQ (PQ a plus)Strong understanding of:Drug substance (DS) processes (upstream/downstream)Experience working with:DeltaV environments (functional collaboration level)Knowledge of:ASME BPE / hygienic piping / fabrication standards💡 Nice to HaveBiologics experience (mAbs, recombinant proteins)Large-scale capital or greenfield projectsVendor management (FAT/SAT)Risk-based CQV (ASTM E2500)⚙️ The Role100% Onsite – North Carolina2-Year ContractHighly visible role on a flagship biologics expansion🔥 Why This Role Stands OutOwn systems end-to-end (design → startup)Work on large-scale biologics manufacturingHigh-impact role with cross-functional leadership exposureBe part of a major U.S. pharma expansion program📩 If you’ve been through design, build, and startup of DS systems and want to be part of something big — let’s connect.","datePosted":"2026-04-29T02:49:45.548Z","dateModified":"2026-04-29T02:49:45.548Z","hiringOrganization":{"@type":"Organization","name":"Technical 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