Downstream Process Engineer

Technical Source
Holly Springs, NC

Technical Source is seeking a skilled Downstream Process Engineer to support an expansion project within a large-scale pharmaceutical / biologics manufacturing facility. The ideal candidate will have significant experience working with stainless steel process equipment and strong familiarity with automation systems, especially DeltaV. This role is focused on providing technical support for downstream processing and filtration operations on afternoon / evening shifts.

Key Responsibilities:

  • Provide process engineering expertise for large-scale stainless-steel equipment in downstream manufacturing.
  • Support and troubleshoot operations involving filtration technologies including depth filtration, ultrafiltration, and tangential flow filtration (TFF).
  • Oversee and optimize processing steps in collaboration with manufacturing, quality, and automation teams.
  • Work closely with DeltaV automation systems—understand sequence of operations, system troubleshooting, and communicate automation needs with technical teams.
  • Document and review process procedures, operating conditions, and equipment changes.
  • Support startup, commissioning, and validation activities for downstream processing equipment.
  • Ensure compliance with cGMP, safety, and regulatory expectations.
  • Learn existing process systems and serve as backup support for lead engineers, working flexibly to meet project timelines.

Required Experience and Qualifications:

  • 5 - 12 years of experience in downstream process engineering within the pharmaceutical, biologics, or related industry.
  • Robust understanding of DeltaV automation systems (not required to program, but must understand and communicate system function).
  • Strong hands-on experience working with large-scale stainless steel processing equipment (single-use system experience alone is not sufficient).
  • Direct involvement with key filtration processes such as depth filtration, ultrafiltration, and tangential flow filtration (TFF).
  • Familiarity with large-scale process operations, cGMP requirements, and troubleshooting.
  • Excellent analytical, communication, and team collaboration skills.
  • Bachelor’s degree in Chemical Engineering, Biochemical Engineering, or a related discipline preferred.

Details:

  • This is 12-month contract position
  • Fully onsite
  • Shift: 3pm – 11pm
Posted 2025-11-12

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