Downstream Process Engineer

Downstream Process Engineer – 2nd Shift (Biologics Manufacturing) | Holly Springs, NC

Technical Source is partnering with a global biopharmaceutical leader to support a major facility expansion in Holly Springs, NC. We are seeking a Downstream Process Engineer with strong experience in large-scale stainless-steel equipment and DeltaV-controlled purification systems. This is a highly visible role supporting equipment startup, commissioning, and operations during a period of accelerated project execution.

Location : Holly Springs, NC

Schedule : 2nd Shift (3pm – 11pm), Monday – Friday

Contract : 12-month engagement with potential to convert

Environment : Heavy stainless-steel drug substance manufacturing

About the Role

You will provide hands-on support for downstream purification operations— depth filtration, ultrafiltration, TFF, chromatography , and related process equipment. You’ll collaborate closely with operations, automation, validation, and quality teams to ensure safe, efficient, compliant manufacturing under cGMP conditions. This newly created role enables additional shift coverage as the expansion accelerates toward operational readiness.

What You’ll Do

• Troubleshoot and support downstream drug substance purification processes (chromatography, filtration, UF / DF, virus inactivation)
• Monitor process performance and ensure cGMP compliance during manufacturing runs
• Partner with automation teams to communicate DeltaV operating needs and system troubleshooting
• Support startup, commissioning, and validation activities (IQ / OQ / PQ, C&Q)
• Execute process improvements to increase yield, optimize cycle time, and enhance product quality
• Serve as backup coverage for lead process engineers, reducing after-hours escalation

What You Bring

Important note for applicants : Experience focused only on single-use systems is not a fit for this role — the facility is “very, very heavy old-school stainless steel.”

Why This Project Matters