Manufacturing Operator

Job Description: 

The Prep Operator (Operator II) will work in and maintain a Grade C/D environment. They will perform routine cleaning and sanitization to help ensure readiness and current Good Manufacturing Practices (cGMP) compliance within the classified and non-classified work areas. Activities shall include cGMP compliant gowning, conformance to Good Documentation Practices (GDP) standards, integrity testing of filters, and cleaning, setup, and sterilization of equipment and components. Ability to operate preparation equipment such as autoclaves, sonicators, depyrogenation ovens, and vial and stopper washers. The Preparation Operator may be required to cross-train as a support Operator for additional areas. This position reports to the Manufacturing Supervisor.

What you’ll be doing:

• Understand and follow current Good Manufacturing Practices
• Perform routine cleanup and sanitizations as assigned by area supervision to maintain cGMP compliance within the Grade C/D work areas
• Perform sanitizations in a timely and effective manner in accordance with cGMPs and procedures, maintaining production schedule
• Maintain organization at all times within the classified areas to ensure segregation, readiness and to prevent any contamination or rejection of batches
• Compare Lot numbers to ensure correct components are being used for the specified batch
• Complete calculations to support preparation activities
• Retrieve and test in-process samples
• Clean and sample equipment
• Required to maintain attendance in accordance with the Bloomington Attendance Policy
• Scheduled weekend overtime will be required

Work Environment:  Classified pharmaceutical environment including wearing required gowning as shown in attached document.  Occasional work with water and pharmaceutical product while wearing applicable Personal Protective Equipment.  Must be able to work safely with materials required to produce pharmaceutical products, including chemicals, compounds, glassware and sanitization solutions.

What you’ll bring:

• High school diploma or GED required
• 6 months of previous Pharmaceutical or Manufacturing experience preferred.
• Ability to work independently
• Good communication skills
• Good documentation skills, including legible handwriting
• Good interpersonal skills
• Basic computer skills
• Basic math skills
• Knowledge of aseptic manufacturing practices
• Knowledge of standard operating procedures, specifications, and job-specific training materials
• Must be able to understand, speak, read and write English
• Must be able to lift, push/pull, and carry up to 70 pounds
• Required to stand for up to 8 hours per day, including constant standing for 2 hours at a time
• Must be able to lift 20 pounds overhead
• Use of hands and fingers to manipulate equipment is required

• Additional Requirement: Final candidates for Prep Operator will be required to pass a post offer/pre-employment job placement examination which will test the physical capabilities to perform the essential functions of the job.