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Manufacturing Operations Specialist
Il y a 2 mois
Manufacturing Operations at Evote
**Job Summary:**
We are seeking a highly motivated and detail-oriented Manufacturing Operations Specialist to join our team at Evote. As a key member of our manufacturing operations team, you will be responsible for assisting in the commissioning, validation, and start-up activities of our manufacturing processes. Post start-up, you will work in the solution and equipment prep area of our facility, ensuring the smooth operation of our manufacturing equipment and processes.
**Responsibilities:**
* Weigh and dispense raw materials for media and buffer preparation, ensuring accuracy and precision in our manufacturing processes.
* Prepare media and buffers in our ISO Class 8 Cleanroom, adhering to strict quality control procedures.
* Perform operations according to Standard Operating Procedures (SOPs), ensuring compliance with company quality systems and safety procedures.
* Execute Electronic Batch Records (EBR) using our Manufacturing Execution System (MES), accurately documenting all manufacturing activities.
* Initiate quality records, including non-conformances (NC), Corrective/Preventative Actions (CAPA), and assist in investigations, ensuring a culture of quality and continuous improvement.
* Ensure compliance with company quality systems, safety procedures, and other company policies, maintaining a safe and healthy work environment.
* Support the operations of manual wash, glasswasher, and autoclave, ensuring the efficient use of resources and minimizing downtime.
* Assemble manufacturing equipment/assemblies for autoclaving, adhering to strict quality control procedures.
* Draft and revise Manufacturing Procedures and Standard Operating Procedures, as necessary, ensuring clarity and accuracy.
* Train other personnel on equipment operation, promoting a culture of knowledge sharing and continuous learning.
* Be available to work various shifts (day, swing, graves, weekends, holidays, as dictated by the production schedule), demonstrating flexibility and adaptability.
**Basic Qualifications:**
* Bachelor's degree and 2 years of Manufacturing & Operations experience; or
* Associate's degree and 4 years of Manufacturing & Operations experience; or
* High school diploma / GED and 6 years of Manufacturing & Operations experience.
**Preferred Requirements:**
* Capacity to develop solutions to technical issues of moderate scope, demonstrating problem-solving skills and analytical thinking.
* Knowledge of cGMP requirements, ensuring compliance with regulatory standards.
* Prior experience with process equipment, promoting a culture of efficiency and productivity.
* Focus on quality and attention to detail, ensuring the highest standards of quality in all manufacturing activities.
* Motivated, self-starter, with a strong desire to learn and grow with the company.
* Good interpersonal, team, and communication skills, promoting a culture of collaboration and open communication.
* Knowledge of Manufacturing Execution System (MES), ensuring seamless integration with our manufacturing processes.
* Troubleshooting skills on scales, mixing equipment, washers, and autoclaves, ensuring minimal downtime and maximum productivity.
**Note:** This job description is intended to describe the general content of the job and to identify the essential functions of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Because job requirements evolve with the changing needs of Evote, this description is subject to change and may be modified at any time, whether formally or informally.
