Biopharma Process Engineer - Downstream (Greenfield)

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 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,

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