Process Engineer
Listed on 2026-06-21
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Engineering
Process Engineer, Validation Engineer, Manufacturing Engineer, Quality Engineering
About the Company
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.
Position OverviewWe are currently seeking an experienced Process Engineer to support the startup and operation of a new Greenfield mammalian cell culture drug substance manufacturing facility in North Carolina. This is a fully onsite position focused on supporting large-scale 15,000L mammalian cell culture operations and process execution within a GMP-regulated biopharmaceutical environment. The ideal candidate will have hands‑on experience in biologics manufacturing, process engineering, and commercial‑scale production support, with strong preference given to candidates with downstream processing expertise (upstream experience is also highly valued).
This individual will work closely with manufacturing, process sciences, validation, and engineering teams to optimize process performance, support facility readiness activities, troubleshoot manufacturing challenges, and ensure successful execution of production campaigns. The role follows a Monday–Friday onsite schedule, with flexibility for extended hours during critical project and manufacturing phases.
- 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 robust qualification and operational readiness.
- Review and approve technical documents, drawings, specifications, and protocols.
- Support process design, troubleshooting, and readiness activities.
- Collaborate with Operations, Validation, Engineering, and Quality to ensure timelines and deliverables are met.
- 5-8+ years of experience in process engineering.
- Masters or Bachelors degree in science and engineering preferred.
- Strong experience in pharmaceutical or biotechnology processing experience will also be considered.
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