FMT Process Engineer

Main Responsibilities & Tasks:

The Process Engineer will execute and support all aspects of technology transfer and process optimization, including:

Technology Transfer & Project Execution

• Lead Process Transfer: Plan and coordinate the transfer of manufacturing processes and technologies from global sending sites to the commercial manufacturing site in Songdo.
• Project Lifecycle Support: Act as the lead Process Engineer during the project phases (IQ/OQ/PQ, start-up) to ensure successful deployment of new technologies and equipment.
• Cross-Functional Collaboration: Partner with MSAT (Manufacturing Science and Technology), sending sites, Engineering, and Quality Assurance teams to proactively identify and resolve technical issues during the transfer process.
• Vendor Management: Manage equipment vendors, contractors, and internal teams to execute equipment commissioning, manage critical spare parts, and support validation activities.
• Timeline & Budget: Ensure all technology transfer activities are completed within agreed-upon timelines and budgets.

Process Optimization & Documentation

• Process Documentation: Develop and document User Requirement Specifications (URS) for process equipment, Standard Operating Procedures (SOPs), safety protocols, and calibration procedures.
• System Optimization: Optimize the systems for efficient troubleshooting and data acquisition.
• Troubleshooting & Improvement: Troubleshoot technical problems and recommend data-driven solutions to optimize product and technology transfer, yield, efficiency, and cost reduction.
• Continuous Improvement: Support the Technology Transfer Lead by implementing site-wide process optimizations, integrating lessons learned from sending sites, and conducting FMEA risk assessments.
• Proactive Maintenance: Lead projects to transition the site towards proactive, predictive, and preventive maintenance methodologies.

Training & Compliance

• Training: Provide technical support and train operators on advanced equipment troubleshooting and control systems.
• Compliance & Safety: Ensure all process and technology transfer activities strictly conform to company, industry, and regulatory requirements (e.g., cGMP), including safety and environmental standards.

• Stakeholder Relations: Develop and maintain strong relationships with internal and external stakeholders, including suppliers and contract manufacturers.

Qualification & Skills:

Education

• BSc or MSc degree in Engineering or a relevant Technical subject.

Experience

• At least 5 years of relevant, proven experience within an operations or manufacturing environment.
• Experience in manufacturing single use consumables for bio/pharmaceutical or bio/pharmaceutical operation using single-use products is preferred.
• Deep knowledge of technical aspects, including process automation and industrial maintenance.
• Proven skills in project management and proficiency with related software.
• Experience in implementing or using ERP and/or MES systems is preferred.

Skills & Attributes

• Expert knowledge of industrial manufacturing process flow.
• Effective and strong leadership skills with the ability to inspire teams.
• Exceptional analytical thinking and effective problem-solving capabilities.
• Excellent communication and interpersonal skills.
• Demonstrated self-motivation and entrepreneurship.

Language

• Communication with both English and Korean is required.

Working 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