Main Responsibilities:
·Already in the planning and engineering phase, you support and align the product and production-specific requirements in cooperation with the responsible plant team and with the global and local engineering team (EMR).
·Monitoring and changing recipes (under change control) during the start-up, qualification and production phase and participating in risk and process deviation analyzes.
·Ensuring the cGMP-compliant documentation (eBR; SOP; operating regulations, etc.) in cooperation with the Bioprocess engineer, Plant Lead and with MSAT. During the water batch, before the start of the production phase, monitoring the functionality of the automated production process and correcting deviations.
·Constantly improving procedures and processes in compliance with the safety, hygiene, environmental and quality requirements in the area of responsibility.
Qualifications and Experience:
· Relevant working/residency permit or Swiss/EU-Citizenship required
·Master’s or Bachelor’s degree in relevant engineering discipline Expertise in the area of Bioprocess Automation (MES Syncade)
·3-5 years of hands on / troubleshooting experience mandatory
·Recognizing risks in relation to security or compliance / Good GMP knowledge
·Structured, focused and well organized work ethic. Solution orientated and Open-minded for new ideas
·Impeccable team and social skills, very good understanding of IT / process control systems. A view for operational optimization potential.
·Ability to communicate internally and externally at higher levels; strong business understanding and strong team orientation
·Working responsible especially with the owned system
·Languages: English fluent