The Reagent Preparation Technician will be responsible for preparing conjugates, reagents and buffers per production processes, conducting sterilization and processes optimization, production equipment operation, maintenance and validation, and will also participate in cleaning validation. This technical will be responsible for production/equipment records accurately, GMP & SOP compliance, quality data analysis, and joining ISO audits, and to enforce workplace safety and cross-functional cooperation.
Main Responsibilities & Tasks
- Check production plans and fulfillment
- Comply with the product process requirements, carefully complete the production tasks of conjugates, reagent and buffer solution preparation, sterilization, and process optimization.
- Be familiar with the operation and maintenance of liquid preparation, be responsible for the implementation and effect evaluation of relevant operating procedures, and participate in the cleaning validation related work.
- Perform daily maintenance and check of production equipment, be familiar with the operation and validation of related equipment.
- After production is completed, promptly clean the site and equipment, and accurately and timely fill in production records and related records of equipment usage.
- Assist in drafting, revising and implementing relevant documents in this area, ensure that the data of this department complies with GMP requirements, ensure that production operations are carried out in accordance with the specified SOPs and have traceable records.
- Complete the relevant data analysis required for the annual report as per the unified requirements of the Quality Department.
- Participate in internal ISO audits and related external audits.
- Strictly run Safety Production System, enhance safety consciousness, strengthen safety management and staff safety education, guarantee without industrial injure in the workshop.
- Maintain good communication, good labor protection and personal protection in the work.
- Actively cooperate with the work of other departments and complete other tasks assigned by the supervisors
Qualifications & Skills
- At least 2 years of production management experience in biopharmaceuticals or pharmaceutical enterprises, familiar with GMP and other vaccine production quality-related regulations, proficient in using pipettes and the operation of disposable liquid dispensing equipment, having experience in using cleaning machines, wet heat sterilization cabinets and other equipment, being familiar with the requirements for cleaning preparations in reagent production, and having experience in aseptic operations as well as 5S, SPC known are preferred
- Strong organizational, coordination and communication skills, strong learning ability, possess teamwork spirit and collaboration ability, Ability to trouble shoot.
- Proficient in operating office software such as Word, Excel, and PowerPoint.
- Familiar with ISO9000, ISO14000, ISO18000.
- Can work under pressure.
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