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.