Sterile Manufacturing 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

This position is responsible for the manufacture of sterile pharmaceutical products. In addition, the employee will perform preparation, compounding, filling and routine facility monitoring.

Responsibilities

• The employee should successfully meet schedules in a high quality and professional manner and ensure production/packaging areas and work areas conform to cGMP, Standard Operating Procedures and Company Policies.
• Maintain the GMP areas in a state of control at all times.
• Independently perform dispensing, manufacturing, and packaging operations following approved Batch Records and routine troubleshooting and cleaning of complex equipment.
• Perform the following duties adhering to written Standard Operating Procedures (SOPs) or written work instructions:
  • Finished Product Inspection and Labeling
  • Restock Manufacturing Consumables
  • Preparation Room Activities
  • Material preparation including component washing and sterilization
  • The set-up, change-over, programming and operation of various manufacturing equipment
  • Compounding Room Activities
  • Prepare stock solutions and drug products
  • Fill Room Operations
  • Operate in ISO5-8 environments
  • Operation of Aseptic Filling machines
  • Cleanroom cleaning and disinfection
  • Complete all activities and documentation as described in Standard Operating Procedures and Policies.
  • Review controlled documents such as sterilization and cleaning logs for accuracy and completeness
  • Assist in revising and writing SOPs relevant to this job function
  • Assist in equipment qualifications
  • Performs other duties as assigned

Qualifications

Education/Experience

• High School degree or equivalent (GED) plus 2 – 5 years’ experience in a cGMP regulated manufacturing environment or at least 1 year experience in Sterile Fill Finish
• Computer skill in Microsoft Excel Office required
• Excellent verbal and written communication skills

Physical Requirements

• Employee must be able to lift or handle objects not more than 50 pounds to perform certain duties essential to the job function.
• Employee may be required to perform tasks essential to the job function in areas that require the use of hearing protection devices.
• Performance of tasks essential to the job function may require the employee to work directly with, handle, or otherwise encounter chemicals or pharmaceutical agents.
• Employee must be able to wear a respiratory protection (filtering facepiece, 1/2 face, full-face, or powered air purifying respirator, supplied air, or self-contained breathing apparatus) for certain tasks essential to the job function.
• Employee must be able to successfully perform cleanroom gowning

Training

• Must successfully complete all departmental training and meet the requirements as part of ongoing training.

Featured Benefits

• Medical insurance
• Vision insurance
• Dental insurance
• 401(k)