Manufacturing Technician

Job Description
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 Corporate 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:

• 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
• The set-up, change-over, programming and operation of various manufacturing equipment
• Fill Room Operations
• Operate in the Class 100 Hood
• Manual Aseptic Filling
• Use of Filling Pumps, Crimper, Capping Machine and Torque Tester
• Cleaning
• Documentation
• Complete all documentation as per Bio-Concept procedures and policies and cGMP regulations
• Review controlled documents such as sterilization and cleaning logs for accuracy and completeness
• Assist in revising and writing SOPs relevant to this job function
• Perform Environmental Monitoring of the Aseptic Manufacturing Suite
• Assist in equipment qualifications

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.