Sterile Fill/Finish Operator

American Injectables; Brooksville (FL); On-site; USD 42,000 - 66,000; Full time

Benefits offered by this job

Medical insurance

Vision insurance

Dental insurance

401(k)

Job summary

American Injectables is seeking a manufacturing professional to support sterile fill finish operations. The role involves preparing, dispensing, and packaging drug products while maintaining strict cGMP and SOP compliance in a cleanroom environment.

The candidate will perform routine equipment setup, calibration, and troubleshooting, and contribute to document control and continuous improvement of SOPs and processes.

Qualifications

• Experience in a cGMP manufacturing environment preferred.
• Ability to follow SOPs and batch records.
• Strong communication skills; written and verbal.

Responsibilities

• Meet schedules in a high quality, professional manner while ensuring production/packaging areas conform to cGMP, SOPs and Company Policies.
• Maintain GMP areas in a state of control at all times.
• Independently perform dispensing, manufacturing, and packaging operations following Batch Records and routine troubleshooting and cleaning of complex equipment.
• Set-up, change-over, programming and operation of various manufacturing equipment.
• Operate in ISO5-8 environments and with aseptic filling equipment.
• Review sterilization and cleaning logs for accuracy and completeness; assist in revising SOPs.
• Assist in equipment qualifications.

Skills

Sterile Fill Finish

cGMP compliance

SOP adherence

Documentation

Education

High School degree or equivalent (GED)

Tools

Microsoft Excel

Job description

American Injectables is seeking a manufacturing professional to support sterile fill finish operations. The role involves preparing, dispensing, and packaging drug products while maintaining strict cGMP and SOP compliance in a cleanroom environment.

The candidate will perform routine equipment setup, calibration, and troubleshooting, and contribute to document control and continuous improvement of SOPs and processes.