Department
Health & Biotech
Category
Health & Biotech
Job type
Full-Time
Experience
5 Years
Description
- 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
Highest qualification: University
- 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.