Location: Marlborough, MA

Shift: 1st Shift Schedule: Monday through Thursday, 5:15 AM to 3:45 PM

OT: Potential overtime on Fridays

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.

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.

PPE Requirements

• Gloves.
• Hair net.
• Safety glasses as needed.
• Pay / Budget

Additional Notes

• Facility operates on a 4x10 schedule.
• Candidates should be comfortable working in a regulated manufacturing environment.
• Focus sourcing efforts on manufacturing, packaging, medical device, pharmaceutical, or other FDA-regulated production backgrounds.