Automation Engineer - all genders -
Core
Automation Engineer supporting clinical trial manufacturing by procuring and integrating new automation units and adapting existing process control systems.
Role type
Senior IC automation engineer (pharmaceutical/biotech)
Builds
Automated manufacturing infrastructure and process control systems for clinical trial drug production
Domain
Pharmaceutical/Biotech manufacturing, Clinical Trial Manufacturing (CTM)
Deliverable
production ML models | product features | infrastructure
Required skills
Automation engineering, Process control systems (ABB 800xA), Procurement of automation units, GMP compliance and qualification documentation, Project management, Industrial networking protocols (PROFIBUS, PROFINET, Modbus), Technical specification creation (URS, FS, DS), GAMP 5 experience
Preferred skills
Experience in pharmaceutical or biotech industry, Coordination of project teams and technical leadership of service providers
Technologies
ABB 800xA, PROFIBUS, PROFINET, Modbus
Responsibilities
Create and review requirement specifications (URS) for new automation units, Evaluate supplier offers and support FAT/SAT, Integrate new units into existing automation infrastructure, Plan, implement, and qualify changes to the process control system (PLS), Ensure GMP compliance and maintain qualification documentation (DQ, IQ, OQ, PQ), Manage project timelines, budgets, and technical execution
Seniority
Senior, hands-on IC