🚀 Senior Process / Equipment Engineer (Drug Substance) – 2-Year Capital Project
📍 North Carolina (Onsite)
🏭 Biologics Manufacturing Expansion
Technical 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 Overview
This is a major capital expansion featuring:
- Five 10,000L stainless steel bioreactors
- One full downstream purification train
The 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 Doing
You will act as the equipment engineering lead for key process systems, including:
- Bioreactors (up to 10,000L)
- TFF (tangential flow filtration) skids
- Chromatography systems
- Viral / depth filtration systems
- Stainless steel tank skids (media, buffer, hold)
Key Responsibilities:
- Lead design reviews (P&IDs, GA drawings, specs)
- Ensure compliance with ASME BPE + hygienic design standards
- Translate process requirements into DeltaV automation strategy
- Partner with Automation on:
- Control strategies
- Interlocks + alarms
- Batch/recipe execution
- Drive systems through:
- Mechanical Completion (MC)
- Commissioning & Qualification (C&Q)
- Startup
You’ll also:
- Support field installation + walkdowns
- Troubleshoot during C&Q + startup
- Coordinate across Engineering, Automation, CQV, Manufacturing, and Quality
🧠 What We’re Looking For
Must-Have Experience:
- Leading design + installation of:
- TFF, Chromatography, Filtration, or Tank Systems
- Hands-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 Have
- Biologics experience (mAbs, recombinant proteins)
- Large-scale capital or greenfield projects
- Vendor management (FAT/SAT)
- Risk-based CQV (ASTM E2500)
� The Role
- 100% Onsite – North Carolina
- 2-Year Contract
- Highly visible role on a flagship biologics expansion
🔥 Why This Role Stands Out
- Own systems end-to-end (design → startup)
- Work on large-scale biologics manufacturing
- High-impact role with cross-functional leadership exposure
- Be 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.
