Operator, Production (Wednesday - Saturday) 7:00am to 5:30pm

Role Summary

Operator, Production (Wednesday - Saturday, 7:00am to 5:30pm). This role requires four 10-hour shifts. You will set up equipment for routine processes, operate complex manufacturing equipment, monitor processes, and communicate events to the appropriate personnel. You will identify opportunities for improvements and implement changes in operations and documentation, with minimal supervision.

Responsibilities

• Knowledgeable of jobs in assigned area of responsibility and Good Manufacturing Practice (GMP) policies. Demonstrates compliance to local and industry quality and safety standards.
• Records work performed in regards to GDP guidelines in a regulated environment.
• Operates either manual or controlled process equipment in an aseptic manufacturing environment with mammalian cell culture.
• Wears gowning for Grade C environment.
• Has knowledge of equipment and manufacturing process and can operate with minimal help of the certified and qualified trainer. Comprehends and applies all required technical, regulatory, and safety training.
• Ability to troubleshoot problem situations with minimal assistance.
• Under minimal supervision makes timely decisions to accomplish department goals. Recommends improved manufacturing and departmental processes, and takes ownership of tasks.
• Listens actively to acquire information and understand work procedures. Participates in the sharing of information to promote overall efficiency of production. Attends and actively participates in meetings.
• Works to resolve conflict in professional and constructive manner with individuals inside and outside operating environment.

Qualifications

• High School diploma or GED required.
• Minimum 1 year experience in a cGMP environment. Clean room environment experience a plus.
• Must have technical knowledge with manufacturing experience in a chemical, biological, pharmaceutical, or similar environment.
• Knowledge of department basic operating procedures and guidelines, compliance and safety rules and procedures relating to normal duties.