About this opportunity
American Injectables lists this Sterile Manufacturing Operator opportunity in brooksville, Florida. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Sterile Manufacturing Operator
Status : Full Time Employee
Overview: 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.
This employee will independently perform dispensing, manufacturing, and packaging operations following approved Batch Records and routine troubleshooting and cleaning of complex equipment. Specifically, this person will 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
Good verbal and written communication skills
Physical Requirements:
Employees must be able to lift or handle objects not more than 50 pounds to perform certain duties essential to the job function.
Employees 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.
Employees 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.
Employees must be able to successfully perform cleanroom gowning
Training:
Must successfully complete all departmental training and meet the requirements as part of ongoing training.
Worksite address
brooksville, FL, 34605, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.