Principal Process Engineer - Upstream​/Downstream

Role

Principal Process Engineer specializing in upstream/downstream biopharmaceutical manufacturing, focused on designing, building, commissioning, and qualifying equipment for drug substance production at a new advanced facility.

lead technical projects, support site design, construction, start-up, and operational readiness; oversee GMP-compliant system installation and validation; provide end-to-end support for process equipment including upstream/downstream systems, and lead process optimization and troubleshooting; support technology transfers, process design, and new product introductions; ensure regulatory compliance and safety standards; mentor junior engineers; and support 24/7 operations with on-call duties.

Doctorate (2+ years), Master’s (4+ years), Bachelor’s (6+ years), or equivalent experience in engineering; 2+ years managerial or leadership experience; proven expertise in biopharmaceutical process and plant engineering, including GMP environments, equipment such as reactors, centrifuges, chromatography, filtration, and associated systems; familiarity with Tech Transfer, process validation, and commissioning.

degree in Chemical or Mechanical Engineering; 8+ years industry experience, especially with biologics manufacturing; hands-on experience with GMP equipment, process automation, and safety standards; excellent leadership, communication, and project management skills.

High-Value: biologics, upstream/downstream processing, GMP, process validation, equipment design, Tech Transfer, 24/7 manufacturing support, and international travel (up to 10%).

Location:

not specified, travel required.