Senior Process Engineer

🚀 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.