Senior Process Engineer

Senior Process Engineer at Technical Source Senior Process Engineer at Technical Source in Fuquay Varina, North Carolina Posted in 10 days ago.

Type:

full-time

Job Description:

???? 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.