Shopfloor Support & SME Role: Provide direct, hands-on technical support for daily production operations. Act as a Subject Matter Expert (SME) to support production operators during the exciting ramp-up phase of the newly established production line
Proactively drive Continuous Improvement initiatives to optimize yield and efficiency
Document & Change Management: Create and maintain robust process documentation, change records, and work instructions in line with GxP standards
Product Care & NC Management: Take ownership of product care activities within the Squad. This includes handling non-conformity notifications, leading structured investigations and root-cause analyses, and coordinating corrective actions in the manufacturing process
Data-Driven Process Monitoring: Monitor production data and analyze production and process performance indicators to ensure process stability and high quality
Global Collaboration & Coordination: Coordinate and collaborate closely with internal and external partners, including exchange with subject matter experts in USA. This requires flexibility regarding working hours for occasional evening meetings due to time zones
Regulatory Compliance: Work strictly according to internal processes defined by the GxP-regulated environment
Profile
University degree in Natural Sciences or Engineering, such as Biotechnology, Biology, Chemistry, Molecular Biology, Material Science, Mechanical or Electrical Engineering, or equivalent professional experience
Professional experience in a highly regulated environment, with strong quality awareness and a GxP mindset
Experience in non-conformity (NC) management, deviations, change control, and technical documentation
Hands-on experience in troubleshooting manufacturing operations and supporting operators during production ramp-up
Experience in Technical Supplier Management (TSM) or related activities, including supplier relationships, technical changes, and process change initiatives
Experience in data-driven process monitoring and analyzing key production performance indicators
Knowledge of experimental planning and execution, ideally including statistical methods such as Design of Experiments (DoE) in laboratory or production environments
Strong communication, teamwork, and coaching skills, with the ability to collaborate across Engineering, Operations, QA, and Logistics and support shopfloor operators as a Subject Matter Expert (SME)
Proactive and independent working style, with a strong interest in manufacturing technologies, process improvement, and taking ownership