Biologics GMP Manufacturing Technician
2 weeks ago
Job Summary
The role includes material management, cleaning and sterilization, formulation, filling and lyophilization, capping, external washing, inspection and packaging, new plant construction, auditing, etc.
Responsibilities
- Responsible for the whole-process management of production materials, consumables, semi-finished products, and finished products, strictly adhering to GMP requirements.
- Possess mastery of DP equipment principles and familiarity with the production process, enabling independent operation and basic maintenance of related equipment.
- Draft and revise relevant operating procedures, batch production records, and related files in accordance with GMP requirements.
- Strictly adhere to change control and deviation investigation processes, organize the drafting and implementation of changes, conduct deviation investigations, and establish corrective and preventive actions.
- Analyze and resolve issues arising in the manufacturing process independently.
- Continuously optimize production processes and workflows to ensure product quality and improve production efficiency.
- Participate in the design and recommendation of new plants.
- Participate in audits related to DP manufacturing.
- Adhere to company compliance requirements.
Qualifications
- Diploma or higher in Pharmaceutical Manufacturing, Pharmaceutical Engineering, Pharmacy, Bioengineering, Biotechnology, Chemical Engineering, Microbiology, or related fields.
- Knowledge of GMP is preferred, with expertise in aseptic production being an advantage.
- Possess a solid foundation in pharmacy and biotechnology, with proficiency in Microsoft Office.
- Strong English language skills and the ability to proactively analyze and solve problems that arise in the workplace.
- Excellent hands-on operational skills, with careful and conscientious equipment operation and timely record-keeping.
- Good communication and expression skills.
- Effective team collaboration, efficient execution, and a strong sense of responsibility.
Training Opportunities
- Production Skills Training: Helps you quickly meet the technical qualification requirements for your current position.
- Equipment Usage Skills Training: Familiarize yourself with the facilities and equipment involved in DP.
- Vocational Training: Become familiar with the characteristics and mechanisms of various biopharmaceutical R&D and production, master the skills of efficiently and reasonably managing time, and enhance your core competitiveness.
- Safety Awareness and Professional Training: The company offers a comprehensive system of safety training materials and experienced instructors.
- Monthly Academic Reports: World-renowned scientists and experts are invited to deliver lectures.
- Management Skills Training: Provided by company executives and renowned training institutions to improve employees' practical and theoretical knowledge.
Team Collaboration
Vacuum Pumps
GMP
Formulation
Microbiology
Biotechnology
Packaging
Change Control
Manufacturing
Chemical Engineering
Safety Training
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