Posted 3 days ago
Production Operator
AI Summary
Assembles and produces single-use biopharmaceutical products in a cleanroom, ensuring GMP compliance, equipment maintenance, and material preparation.
About this role
This position is responsible for the assembly and production of essential, high-reliability single-use products for the biopharmaceutical manufacturing process at Sartorius Korea Operations (Songdo). By maintaining strict GMP compliance in a Clean Room and overseeing equipment maintenance and material prep, you will provide the operational excellence necessary for our clients' bioprocessing success.
This position is responsible for the assembly and production of essential, high-reliability single-use products for the biopharmaceutical manufacturing process at Sartorius Korea Operations (Songdo). By maintaining strict GMP compliance in a Clean Room and overseeing equipment maintenance and material prep, you will provide the operational excellence necessary for our clients' bioprocessing success.
Main Responsibilities & Tasks:
- Manufacturing & Assembly: Assemble and support the production of single-use products for biopharmaceutical manufacturing, with a strong focus on product integrity and quality.
- GMP Compliance & Documentation: Execute tasks in strict accordance with Standard Operating Procedures (SOPs) and GMP regulations, while accurately maintaining and managing production logbooks.
- Site & Material Management: Maintain workplace cleanliness through scheduled cleaning and ensure optimal inventory levels by collaborating with the logistics team and utilizing inventory management systems.
- Waste Disposal: Perform site sanitation and ensure the safe disposal of process waste following approved protocols.
- Safety & Quality Assurance: Adhere to all safety and quality guidelines, perform routine safety inspections and preventive maintenance, and provide support or technical input during quality deviations.
- Training & Continuous Improvement: Support the onboarding and training of new hires on company policies/procedures and participate in process improvement initiatives to enhance safety and quality in coordination with management.
Qualifications & Requirements:
Qualification:
- Education: High school diploma or equivalent (Associate degree or higher in a related field).
- Essential Skills: Strong safety awareness, sense of responsibility, and excellent collaboration skills.
Preferred Qualification:
- Experience in GMP production or quality control within the pharmaceutical/biotech industry.
- Experience with GDP (Good Documentation Practice).
- Understanding of and ability to operate mechanical equipment.
- Experience in process improvement activities and a high level of understanding of GMP regulatory standards.
- Proficiency in MS Office (Word, Excel, PowerPoint, etc.).
Working Conditions/Environment:
- Work Schedule: Standard 8 hours per day; however, flexibility for overtime or shift work is required based on production demands.
- Physical Stamina: Ability to work while standing for extended periods.
- Physical Capability: Capability to lift, push, or pull objects weighing up to 20kg.
- PPE Compliance: Mandatory use of Personal Protective Equipment (PPE) within the cleanroom, including masks, safety shoes, gloves, and full-body cleanroom suits.
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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