CCM Process Engineer
Sartorius · Kaesŏng
We are recruiting process engineers to lead the Songdo CCM (Cell Culture Media) project at Sartorius Korea Operations, a leading company in bioprocess solutions. We play a pivotal role in transferring technology from global sites to the Songdo site (Technology Transfer) and laying the foundation for processes from facility construction to commercial production.We are recruiting process engineers to lead the Songdo CCM (Cell Culture Media) project at Sartorius Korea Operations, a leading company in bioprocess solutions. We play a pivotal role in transferring technology from global sites to the Songdo site (Technology Transfer) and laying the foundation for processes from facility construction to commercial production.
Responsibilities:
- Process & Tech Transfer: Lead and coordinate the transfer of manufacturing processes and technologies from global sites to Songdo commercial site.
- Project Lifecycle Support: Act as the lead engineer for IQ/OQ/PQ and start-up phases to ensure successful deployment of equipment.
- Cross-Functional Collaboration: Partner with MSAT, Engineering, and QA teams to proactively resolve technical issues during the transfer.
- Vendor & Asset Management: Manage equipment vendors and contractors for commissioning, validation, and critical spare parts management.
- Documentation & Optimization: Develop URS, SOPs, and calibration procedures; optimize systems for data acquisition and troubleshooting.
- Continuous Improvement: Troubleshoot technical problems using data-driven solutions; lead FMEA risk assessments and site-wide process optimizations.
- Maintenance & Training: Transition the site towards predictive/preventive maintenance; provide technical training to operators.
- Compliance & Safety: Ensure all activities strictly conform to cGMP, industry regulations, and safety/environmental standards.
Qualifications & Requirements:
Qualification:
- Education: BSc or MSc degree in Engineering or a relevant technical field.
- Experience: Minimum 5 years of proven experience in an operations or manufacturing environment.
- Preferred Experience: Manufacturing of cell culture media (CCM) for biopharmaceuticals or bio-ops using CCM; experience with ERP/MES systems.
Specialized Knowledge & Skills:
- Technical Expertise: Deep knowledge of industrial manufacturing process flow, process automation, and industrial maintenance.
- Project Management: Proven skills in project management methodologies and related software proficiency.
- Soft Skills: Exceptional analytical thinking, problem-solving, and strong leadership to inspire teams.
- Mindset: Demonstrated self-motivation, entrepreneurship, and effective interpersonal skills.
Language:
- Fluency in both English and Korean is required for global stakeholder communication and technical documentation.
Working Conditions/Environment:
- Willingness to travel locally or globally as needed to support technology transfer and project phases.
About Sartorius
Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide.
We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment.
Join our global team and become part of the solution. We are looking forward to receiving your application.
www.sartorius.com/careers
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