Sterile Manufacturing Operator

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.