Sterile Manufacturing Operator Jobs

– Sterile Manufacturing Operator

Overview:

This position is responsible for the manufacture of sterile pharmaceutical products. In addition, 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 trouble-shooting and cleaning of complex equipment. Specifically, this person will perform the following duties adhering to written Standard Operating Procedures (SOPs) or written work instructions:

• Complete all activities and documentation as described in Standard Operating Procedures and Policies.
• Cleanroom cleaning and disinfection
• Material preparation including component washing and sterilization
• Assist in equipment qualifications
• Operation of Aseptic Filling machines
• Perform Environmental Monitoring of the Aseptic Manufacturing Suite
• Review controlled documents such as sterilization and cleaning logs for accuracy and completeness
• Assist in revising and writing SOPs relevant to this job function
• Prepare stock solutions and drug products
• Finished Product Inspection and Labeling
• Preparation Room Activities
• Fill Room Operations
• Restock Manufacturing Consumables
• The set-up, change-over, programming and operation of various manufacturing equipment
• Operate in ISO5-8 environments
• Compounding Room Activities

Requirements

Qualifications:

Education and 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 and Word required. Good verbal and written communication skills.

Physical:

• 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 may be required to perform tasks essential to the job function in areas that require the use of hearing protection devices.
• Employees must be able to lift or handle objects not more than 50 pounds to perform certain duties essential to the job function.
• Employee must be able to successfully perform cleanroom gowning
• Performance of tasks essential to the job function may require the employee to work directly with, handle, or otherwise come into contact with chemicals or pharmaceutical agents.

Training:

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

BenefitsContract Position