Senior Process Engineer

🚀 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.