Process Engineer

S4 Analytics LLC

Wilson (NC)

On-site

USD 95,000 - 140,000

Full time

3 days ago
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Job summary

S4 Analytics is seeking an experienced Process Engineer to support a new Greenfield mammalian cell culture drug substance facility in Wilson, NC. The role focuses on 15,000-liter mammalian cell culture operations with a preference for downstream purification expertise.

The position is fully onsite, Monday-Friday, with potential extended hours during execution phases. The ideal candidate will bring 7+ years in biopharma manufacturing engineering, experience with large-scale biologics facilities,

Qualifications

  • 7+ years experience in biopharma or biotech manufacturing engineering.
  • Strong preference for downstream purification experience; upstream mammalian cell culture experience also beneficial.
  • Experience with large-scale biologics facilities, Greenfield projects, or system ownership activities.
  • Ability to operate effectively in a fast-paced construction/startup environment.

Responsibilities

  • Serve as system owner for assigned equipment and process areas within a new Greenfield manufacturing site.
  • Oversee vendor interactions, FAT/SAT support, installation, commissioning readiness, and documentation review.
  • Ensure equipment is delivered, installed, and tested to support qualification and operational readiness.
  • Review and approve technical documents, drawings, specifications, and protocols.
  • Support process design, troubleshooting, and readiness activities as equipment arrives through July.
  • Collaborate with Operations, Validation, Engineering, and Quality to ensure timelines and deliverables are met.

Skills

Biopharma manufacturing engineering
Downstream purification
Upstream mammalian cell culture
System ownership
Startup environment adaptation

Job description

S4 Analytics is a growing consulting and workforce solutions firm headquartered in Texas and New Jersey, specializing in connecting highly skilled professionals with leading organizations across the Life Sciences, Semiconductor, Automotive, Defense, Data Center, and IT industries. We are committed to building long-term partnerships by delivering top talent and customized staffing solutions that support our clients’ evolving business and project needs.

Summary:

My client is seeking an experienced Process Engineer to support a new Greenfield mammalian cell culture drug substance facility in Wilson, NC. This role focuses on supporting 15,000-liter mammalian cell culture operations, with a strong preference for candidates who bring downstream processing experience (upstream experience also valued). The position is fully onsite, Monday-Friday, with the potential for extended hours during execution phases.

Key Responsibilities
  • Serve as system owner for assigned equipment (UF/DF, chromatography systems, buffers, etc.) and process areas within a new Greenfield manufacturing site.
  • Oversee vendor interactions, FAT/SAT support, installation, commissioning readiness, and documentation review.
  • Ensure equipment is delivered, installed, and tested to support robust qualification and operational readiness.
  • Review and approve technical documents, drawings, specifications, and protocols.
  • Support process design, troubleshooting, and readiness activities as equipment arrives through July.
  • Collaborate with Operations, Validation, Engineering, and Quality to ensure timelines and deliverables are met.
Experience Requirements
  • 7+ years experience in biopharma or biotech manufacturing engineering.
  • Strong preference for downstream purification experience; upstream mammalian cell culture experience is also beneficial.
  • Background supporting large-scale biologics facilities, Greenfield projects, or system ownership activities.
  • Ability to operate effectively in a fast-paced construction/startup environment.
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