As the Shift Leader for the FMT production site, you will be responsible for overseeing shift operations and ensuring production targets are met. With over 10 years of expertise, you will supervise GMP compliance and lead the technical training and safety management of field operators. Beyond standard manufacturing, you will act as a hands-on leader dedicated to process optimization and deviation prevention, ensuring the stable and efficient operation of the Songdo site.
As the Shift Leader for the FMT production site, you will be responsible for overseeing shift operations and ensuring production targets are met. With over 10 years of expertise, you will supervise GMP compliance and lead the technical training and safety management of field operators. Beyond standard manufacturing, you will act as a hands-on leader dedicated to process optimization and deviation prevention, ensuring the stable and efficient operation of the Songdo site.
Main Responsibilities & Tasks:
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Shift Management & Oversight: Lead shift operations, including manpower allocation, production scheduling, and supervising the achievement of daily production targets.
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GMP & Quality Supervision: Monitor all onsite processes to ensure strict adherence to SOPs and GMP regulations; support the review and approval of Batch Records.
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Troubleshooting & Issue Resolution: Provide immediate corrective actions and root cause analysis for technical issues or equipment failures occurring during production.
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Talent Development & Mentorship: Manage On-the-Job Training (OJT), technical guidance, and competency evaluations for new hires and junior operators.
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EHS (Environment, Health, and Safety) Leadership: Supervise safety protocol compliance within the shift, lead Near Miss reporting, and proactively identify/eliminate workplace hazards.
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Cross-functional Collaboration: Communicate effectively with Logistics, Quality (QA/QC), and Engineering departments to optimize production planning.
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Continuous Improvement (CI): Analyze shop-floor data to eliminate waste, improve production yields, and implement cost-reduction initiatives.
Qualifications & Requirements:
Qualification:
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Education: High school diploma or equivalent (Associate degree or higher in a related field preferred).
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Experience: Minimum 10 years of experience in pharmaceutical, biotech, or related manufacturing environments.
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Leadership: At least 3–5 years of experience in a leadership or supervisory role (e.g., Team Lead or Supervisor).
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Technical Skills: Deep understanding of GMP environments and high proficiency in process management and equipment operation.
Preferred Qualification:
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Experience in Single-use bioprocessing and Clean Room operations.
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Experience with Deviation management and CAPA (Corrective and Preventive Action) processes.
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Proficiency in ERP (SAP, etc.) and MES (Manufacturing Execution Systems).
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Basic English communication skills (ability to understand global guidelines, etc.).
Working Conditions/Environment:
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Shift Flexibility: Must be able to work rotating shifts and overtime based on production requirements.
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Physical Requirements: Physical stamina to perform long-term onsite management and work within a Clean Room environment wearing full PPE (cleanroom suits).
