Sterile Fill Production Machine Operator (Midnights)

Endo • Rochester, MI

99d

About The Position

At Endo, we are building a diverse, equitable and inclusive workplace, and we are looking for talented individuals to join our team. In accordance with Current Good Manufacturing Practices, Standard Operating Procedures (written and/or oral) instructions and Safety Regulations are responsible for the continuity of complex operations required to maintain production.

Requirements

• High School Diploma, GED or equivalent.
• Successful completion of in-house training programs (includes Upgrader Exam).
• Knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
• Arithmetic Aptitude preferred.
• Pressure and Temperature Aptitude preferred.
• Mechanical Aptitude preferred.
• Hand Tools and Measuring Instruments Aptitude preferred.

Responsibilities

• Sets-up, checks, adjusts and runs production equipment as required by product and size change over.
• Communicates effectively and on a timely basis to fill and seal operators.
• Coordinates with Area Supervisors to ensure an efficient filling operation.
• Communicates with Supervisor in a proactive manner with respect to line operating conditions, product quality status, and potential improvements.
• Cleans lubricates, starts, stops and services equipment necessary to promote and maintain a smooth & efficient flow of production.
• Performs required environmental and personnel monitoring sampling and recording when necessary.
• Determines and verifies that correct and adequate labels, materials and supplies have been provided to meet production schedules.
• Maintains a continuous supply of materials to production lines.
• Notifies Area Supervisor of processes or equipment not in a state of regulatory compliance when discovered.
• Documents all line clearance forms and other documentation forms necessary for the processing of each batch.
• Records downtime, production output and other manufacturing documents as assigned.
• Maintains eligibility for core qualification.
• Tests integrity of sterilizing filters.
• Performs other duties as assigned by Area Supervisor.

What This Job Offers

• Education Level: High school or GED
• Number of Employees: 1,001-5,000 employees