Formulation & Preparation Operator

The Formulation & Preparation Operator (Operator II & III) position supports aseptic filling operations by staging and delivering components, conducting in-process testing, weighing materials, formulation of product, filtration, cleaning, sanitization, sterilization of equipment, batch reconciliation, compliant gowning, setup and operation of parts washers, autoclaves, and tank cleaning in conformance with cGMP/GDP standards. The operator also initiates minor revisions to existing documents and troubleshoots simple process/equipment failures.

The operator may be required to cross‑train as a support operator for additional areas. This position reports to the Manufacturing Supervisor.

• Understand and follow current Good Manufacturing Practices (GMP)
• Understand and follow current Good Documentation Practices (GDP)
• Perform routine cleanup, line clearances, and sanitizations as assigned by area supervision to maintain cGMP compliance within the cleanroom work areas; perform sanitizations in a timely and effective manner in accordance with cGMP and Simtra procedures, maintaining production schedule.
• May be required to cross‑train as a support operator to assist additional manufacturing areas.
• Maintain organization at all times within the classified areas to ensure equipment segregation, readiness, and to prevent any contamination or rejection of batches.
• Perform routine verification of equipment and instruments.
• Compare lot numbers to ensure correct components are used for the specified batch.
• Complete calculations to support preparation and formulation activities.
• Retrieve and test in‑process samples.
• Clean, sterilize, and sample equipment.
• Set up and operate autoclaves, parts washers, tank cleaning, and formulation stations in cleanroom areas.
• Assist in the training and development of other team members.
• Required to maintain attendance in accordance with the Bloomington Attendance Policy.
• Scheduled weekend overtime may be required.

• High school diploma or GED required; 6 months of previous pharmaceutical or manufacturing experience preferred.
• Must be able to understand, speak, read and write English to comply with necessary SOPs, job‑specific training materials, GMPs, and other manuals.
• Basic computer skills in Microsoft Word, Excel, Outlook, and ability to use enterprise software (examples include Veeva, D365, Blue Mountain, etc.).
• Must have the ability to work effectively in a “hands‑on environment” capable of troubleshooting complex equipment and systems.
• Competency in operation of multiple types of equipment related to the manufacturing operations as well as hand‑operated equipment including, but not limited to, calipers, scales, gauges, and other measuring devices; ability to demonstrate proficiency in reading equipment drawings; ability to work safely with equipment under pressure.

• Must be able to lift and carry up to 70 lbs, and push and pull up to 150 lbs.