Operations Associate - CleanPac

Monday – Thursday, 10-hour days

About the role

The Operations Associate supports proper cleanroom operations, policies, procedures, and work instructions while maintaining regulatory compliance in every task. This position ensures product integrity, traceability, and proper labeling and packaging through accurate documentation. Tasks include operating automated machinery, product assembly, preventative maintenance, and cleanroom monitoring, with additional duties assigned based on business needs.

Responsibilities

• Perform routine cleaning, maintenance, and monitoring of cleanroom and controlled area operations.
• Operate process equipment, such as automated machinery, measurement tools, and label printers.
• Perform assembly and packaging of medical devices.
• Maintain product integrity and traceability through proper documentation of Manufacturing Orders.
• Actively engage in shutdowns and other events affecting operational status.
• Assist the engineering team in troubleshooting efforts and other operational tasks.
• Maintain a safe work environment and adhere to regulated products in a regulated environment.
• Adhere to the Quality Management System and support all quality initiatives.
• Maintain regulatory batch records for each operational task and assigned equipment.
• Assist in cleanroom inventory control as necessary.

Requirements

• Must be detail-oriented, able to follow directions, and adhere to work instructions and procedures in a structured environment.
• Ability to complete tasks independently without constant supervision.
• Experience with Microsoft Office Suite, including Excel.
• Must be able to work in a cleanroom environment utilizing required garments and PPE.

Qualifications

• High School Diploma and/or combination of experience.
• Minimum 2 years’ experience in a production or shop environment (preferred).
• Medical device manufacturing experience (preferred).
• Cleanroom manufacturing experience (preferred).

Benefits

• Two comprehensive medical plan options available the first of each month following hire.
• Flexible Spending Account or HSA Account.
• Vision benefits.
• Company-paid dental insurance for employee and dependents.
• Wellness plan.
• 401k with 5% matching.
• Generous PTO plan including 11 paid holidays, 2 floating holidays, and community service hours.
• Company-paid short-term disability.
• Long-term disability coverage.
• Company-provided life insurance.
• Paid parental leave.
• Casual dress code.
• Social events for employees and family.