Operations Associate - CleanPac

BioHorizons; Northern (KY); Hybrid; USD 36,000 - 48,000; Full time

Benefits offered by this job

Medical insurance

401k with matching

Paid time off

Vision benefits

Dental insurance

Life Insurance

Parental leave

Casual dress code

Company events

Job summary

BioHorizons seeks an Operations Associate to support cleanroom operations, regulatory compliance, and documentation. You will operate automated machinery, assemble and package medical devices, and ensure traceability through proper labeling and Manufacturing Orders.

Role emphasizes adherence to Quality Management System, PPE, and a safe regulated environment, offering cross-functional collaboration and process improvement within a production setting.

Qualifications

• High School Diploma or equivalent; 2 years of production/shop experience preferred.
• Experience in a cleanroom environment and PPE protocols.
• Medical device manufacturing experience is preferred.
• Detail orientation and ability to follow work instructions within a structured environment.

Responsibilities

• Perform routine cleaning, maintenance, and monitoring of cleanroom and controlled area operations.
• Operate process equipment, including automated machinery and label printers.
• Assemble and package medical devices.
• Maintain product traceability and documentation for Manufacturing Orders.
• Assist in shutdowns and events that affect operations.
• Support engineering troubleshooting and other tasks impacting operations.
• Maintain a safe, compliant work environment and adhere to Quality Management System.

Skills

Detail oriented

Follow directions

Independent worker

PPE compliance

Education

High School Diploma

Tools

Excel

Microsoft Office

Job description

Work Schedule: Monday - Thursday 10 hr. days

The Operations Associate will support proper cleanroom operations, policies, procedures, and work instructions. This role must maintain and ensure Regulatory Compliance in every work task. This position is primarily responsible for ensuring product integrity, traceability and proper labeling and packaging through the accurate documentation of each aspect of their job function. Tasks may include operating automated machinery, product assembly, preventative maintenance, and cleanroom monitoring. Other duties may develop over time based on business needs and availability.

Essential Duties and Responsibilities:

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

Qualifications:

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

Education:

• High School Diploma and/or combination of experience.
• Minimum 2 years’ experience in a production or shop environment is preferred.
• Medical Device manufacturing preferred.

• Cleanroom manufacturing experience preferred.

Benefits:

• 2 comprehensive medical plan options to choose from available the first of each month following your date of hire
• Flexible Spending Account or HSA Account available
• 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
• Company provided Life Insurance
• Paid Parental Leave
• Casual Dress Code
• Social events for employees and family

Henry Schein, Inc. is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.

Please note that any offer of employment made by BioHorizons is contingent upon the successful completion of a pre-employment background investigation to include a pre-employment drug screen.