Manufacturing Operations Specialist
il y a 4 jours
Job Summary:
Just Evotec Biologics EU is seeking a highly skilled Manufacturing Associate III to join our team. As a key member of our manufacturing operations team, you will be responsible for ensuring the successful execution of clinical and commercial manufacturing operations while maintaining cGMP compliance.
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 stay up-to-date with industry developments.
- 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.
- Perform other duties as assigned.
Basic Qualifications:
- 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
Qualification Requirements:
- 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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