Spezialist Prozesstechnik & Prozessvalidierung (m/w/d) - GMP-Produktion
Core
Specialist in process technology and process validation for GMP-compliant production, bridging production, quality, and technical operations.
Role type
Process Technology & Validation Specialist (GMP Production)
Builds
GMP-compliant biotechnology and life science products
Domain
Life Sciences / Biotechnology / GMP Manufacturing
Required skills
Process analysis and optimization, Process validation planning and execution, Deviation investigation and root cause analysis, Process transfer and scale-up, SOP and documentation creation, Change control and CAPA management, Statistical process data evaluation
Preferred skills
Experience in process validation and qualification, Deviation management, Cleanroom or sterile production knowledge, Cell culture media and buffer knowledge, Single-use system knowledge, Statistical process evaluation
Technologies
GMP, SOPs, CAPA, Change Control, Statistical Process Control
Responsibilities
Analyze and optimize production processes, Plan and execute process validations, Investigate and resolve deviations, Plan and evaluate process trials, Transfer new products and technologies to production, Collaborate on scale-up and equipment qualification, Create and update SOPs and process documentation, Analyze process data and trends, Collaborate with production, QA, lab, and maintenance teams