Machine Operator

Key Responsibilities:

• Operate manufacturing equipment according to SOPs and work instructions.
• Monitor equipment performance and maintain operational logbooks.
• Support preventative maintenance activities.
• Assist with material handling and inventory control.
• Maintain GMP compliance and product quality standards.
• Complete production documentation accurately.
• Report unresolved production or equipment issues to leadership.

Required Skills:

• Strong attention to detail.
• Packaging/manufacturing background.
• Experience working in an FDA-regulated environment.

Preferred Skills:

• Team-oriented mindset.
• Positive attitude.
• Ability to adapt and pivot to changing priorities.

Summary of Duties and Responsibilities:

• Monitor functions of equipment and operate per documented procedures including maintaining operational logbooks
• Provide technicians with symptoms of equipment failures, when required
• Assist in Preventative Maintenance PM following procedures
• Support material handling as necessary
• Maintain segregation of materials and lot and or receiving numbers
• Maintain area in a clean and orderly condition
• Adhere to and demonstrate compliance to all company and department standard operating procedures including but not limited to: GMP, device history record, hazard communication and safety rules
• Utilize written procedures and training to accomplish tasks noted above
• Accept full accountability for product quality
• Report to supervisor or management unsolved problems encountered during the workday
• Maintain complete and accurate records of work-in-process, component inventories and relative documentation
• Under the direction of the Manufacturing Supervisor, the Machine Operator will operate manufacturing equipment according to established specifications, and standard operating procedures and work instructions. An operator must demonstrate steady progress in learning all equipment and jobs in the assigned manufacturing area.
• He and or she must also exhibit the ability to follow instructions of supervisor while observing the quality of raw and finished goods before, during and after production.