Manufacturing Associate III
il y a 1 semaine
Evotec Biologics EU is seeking a highly skilled Manufacturing Associate III to join our team. As a key member of our manufacturing operations, 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 products.
- Perform basic tasks such as sampling and routine maintenance of lab equipment.
- Comply with written procedures for safety requirements, cGMP Practices, Standard Operating Procedures, and manufacturing documentation.
- Assist in media and buffer compounding.
- 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.
- Propose and test solutions to MFG Operational problems with minimal supervision.
- Actively participate in departmental teams and NPI, presenting run data as applicable.
- Train junior-level staff.
- Respond to equipment alarms with the help of the Floor Lead.
- Effectively communicate with the 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 a cGMP manner.
- Demonstrate situational leadership within MFG and company responsibilities.
- Master's degree or equivalent experience.
- Bachelor's degree and 3 years of Manufacturing & Operations experience or equivalent.
- Associate's degree and 5 years of Manufacturing & Operations experience or equivalent.
- High school diploma/GED and 7 years of Manufacturing & Operations experience or equivalent.
- 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.
Evotec Biologics EU is an equal opportunities employer and welcomes applications from all qualified candidates, including those with disabilities.
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