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Manufacturing Operations Specialist
Il y a 2 mois
We are seeking a highly motivated and detail-oriented Manufacturing Associate to join our team at Evote. As a key member of our production team, you will be responsible for assisting in the commissioning, validation, and start-up activities of our manufacturing processes.
Responsibilities- Assist in the preparation of media and buffers in an ISO Class 8 Cleanroom.
- Perform operations according to Standard Operating Procedures (SOPs) and Electronic Batch Records (EBR) using Manufacturing Execution System (MES).
- Initiate quality records, including non-conformances, Corrective/Preventative Actions (CAPA), and assist in investigations.
- Ensure compliance with company quality systems, safety procedures, and other company policies.
- Support operations of manual wash, glasswasher, and autoclave.
- Assemble Manufacturing equipment/assemblies for autoclaving.
- Draft and revise Manufacturing Procedures and Standard Operating Procedures, as necessary.
- Train other personnel on equipment operation.
- Available to work various shifts, including weekends and holidays, as dictated by the production schedule.
- 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.
- Capacity to develop solutions to technical issues of moderate scope.
- Knowledge of cGMP requirements.
- Prior experience with process equipment.
- Focus on quality and attention to detail.
- Motivated, self-starter.
- Good interpersonal, team, and communication skills.
- Knowledge of Manufacturing Execution System (MES).
- Troubleshooting skills on scales, mixing equipment, washers, and autoclaves.
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's business, this description is subject to change and may be modified at any time, whether formally or informally.
