(Fixed-Term) GMP Engineering Specialist
Core
Engineering owner for GMP manufacturing equipment enabling operability and reliability across mRNA process platforms.
Role type
Senior Process Engineer (GMP Manufacturing)
Builds
Gold-standard batches and first-time-right processing for mRNA vaccines
Domain
Biopharmaceuticals / mRNA manufacturing
Required skills
GMP/GxP compliance, root cause analysis, CAPA implementation, change control management, technical writing, equipment troubleshooting, project management
Preferred skills
Bioprocess equipment experience, statistical analysis, digital/AI-driven monitoring tools
Technologies
Ultrafiltration, Chromatography, TMIX, Single Use Mixers, Buffer Prep Vessels, Fermenters, Reaction Vessels, Temperature Control Units
Responsibilities
Provide direct engineering support for critical GMP manufacturing equipment; Lead small-to-medium technical projects balancing quality and timelines; Troubleshoot complex mechanical or process issues; Manage change controls, deviations, and quality records; Support facility fit and tech transfer activities; Contribute to continuous improvement of preventative maintenance strategies
Seniority
Senior, hands-on IC
