Clinical Manufacturing Associate
il y a 4 jours
We are seeking a highly skilled Manufacturing Associate III to join our team at Just Evotec Biologics EU. This role will be responsible for the successful execution of clinical and commercial manufacturing operations while ensuring compliance with cGMP regulations.
Key Responsibilities- Initiate quality records, including non-conformances, Corrective/Preventative Actions, and assist in investigations.
- Complete assigned tasks in a timely manner and demonstrate proficiency in quality management systems, safety requirements, and cGMP practices.
- Actively work to complete training requirements and maintain a high level of technical expertise.
- Set up, operate, and maintain manufacturing equipment, collect data, and write/update GMP documentation with minimal supervision.
- Propose and test solutions to manufacturing operational problems with direction from Floor Lead/Supervisor.
- Participate in departmental teams, NPI, and present run data as applicable.
- Train junior-level staff and respond to equipment alarms with the help of Floor Lead.
- Effectively communicate with Floor Lead/Supervisor the status of manufacturing operations and document operational requirements in batch records.
- Develop an understanding of equipment and operations used to manufacture biotherapeutics in a cGMP manner.
- Demonstrate situational leadership within manufacturing and company responsibilities.
- Be open to change and manage emotions during periods of organizational change.
- Bachelor's degree and 3 years of manufacturing and operations experience; or
- Associate's degree and 5 years of manufacturing and operations experience; or
- High school diploma/GED and 7 years of manufacturing and operations experience
- Capacity to develop solutions to technical issues of moderate scope
- Train other personnel on equipment operation
- Draft and revise SOPs
- Proven knowledge of cGMP requirements to ensure compliance
- Experience in operations required for the manufacture of biotherapeutics
- Focus on quality and attention to detail
- Ability to organize, analyze/interpret, and effectively communicate data and results
- Motivated, self-starter with strong mechanical aptitude
- Good interpersonal, team, and communication skills
- Troubleshooting skills on manufacturing equipment, including single-use equipment
- Experience with Delta V/MES
- Experience with lab equipment/testing
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