Manufacturing Associate III
il y a 2 jours
**Job Summary**
Just Evotec Biologics EU is seeking a highly skilled Manufacturing Associate III to join our team in the production of biotherapeutics. As a key member of our manufacturing team, you will be responsible for executing process recipes, monitoring equipment and processes, and performing basic tasks such as sampling and routine maintenance of lab equipment.
**Key Responsibilities**
- Execute process recipes and monitor equipment and processes to ensure high-quality product production.
- Perform basic tasks such as sampling and routine maintenance of lab equipment to support downstream manufacturing operations.
- Comply with written procedures for safety requirements, cGMP Practices, Standard Operating Procedures, and manufacturing documentation.
- Assist in media and buffer compounding as needed.
- Support the introduction of new products and technologies into the facility.
- Initiate quality records, including non-conformances, Corrective/Preventative Actions, and assisting in investigations.
- Draft and revise Manufacturing Procedures and Standard Operating Procedures as necessary.
- Set up, operate, and maintain a majority of MFG equipment, collect data, and write/update GMP documentation with minimal supervision.
- Propose and test solutions to MFG Operational problems with direction from Floor Lead/Supervisor.
- Actively participate in departmental teams and NPI, presenting run data as applicable.
- Train Junior level staff.
- Respond to equipment alarms with help of Floor Lead.
- Effectively communicate with Floor Lead/Supervisor the status of MFG Operations.
- Document operational requirements in batch records in accordance with cGMP and company guidelines.
- Develop an understanding of equipment and operations used to manufacture biotherapeutics in cGMP manner.
- Demonstrate situational leadership within MFG and company responsibilities.
**Basic Qualifications**
- Master's degree; or
- Bachelor's degree and 3 years of Manufacturing & Operations experience; or
- Associate's degree and 5 years of Manufacturing & Operations experience; or
- High school diploma/GED and 7 years of Manufacturing & Operations experience
**Preferred Requirements**
- Single use technology 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
- Be open to change and manage emotions during periods of organizational change.
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