Prozessingenieur*in - GMP Produktion (m/w/d)
Core
Design, qualify, and operate GMP-compliant production facilities and infrastructure for the synthesis of synthetic nucleic acids.
Role type
Process Engineer (GMP Production)
Builds
GMP production infrastructure and synthetic nucleic acid manufacturing systems
Domain
Life Sciences / Biotechnology / GMP Manufacturing
Required skills
GMP-regulated production experience, plant qualification, technical documentation, HVAC/NEA/Clean Media/Lyophilization knowledge, EMSR basics, project planning
Preferred skills
Degree in Chemical Engineering/Mechanical Engineering/Chemistry/Biotechnology, experience in pharmaceutical manufacturing, technical training with further qualification
Technologies
HVAC, NEA, Clean Media, Lyophilisation, EMSR
Responsibilities
Design and qualify production plants and systems per GMP, create technical specifications and documentation (URS, SOPs, flow diagrams), coordinate external trades, conduct plant acceptance tests, ensure smooth operation via preventive maintenance, optimize nucleic acid synthesis processes, participate in audits
Seniority
Mid-Senior, hands-on IC
