Summary:
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, and conducting in-process testing, filtration, cleaning and sanitization, sterilization of equipment, batch reconciliation, compliant gowning, setup and operation of parts washer, autoclaves, and tank cleaning in conformance with current Good Manufacturing Practices and Good Documentation Practices (cGMP/GDP) standards. The Operator will also initiate minor revisions to existing documents and troubleshoot simple processes/equipment failures. The Operator may be required to cross-train as a support Operator for additional areas. This position reports to the Manufacturing Supervisor.
Essential Duties and Responsibilities (these are primary responsibilities of the role and the incumbent will perform other duties as assigned):
• 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 being used for the specified batch. • Complete calculations to support preparation and formulation activities. • Retrieve and test in-process samples. • Clean, Sterilize, and sample equipment. • Setup 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.
Job Requirements (Education, Experience, and Qualifications):
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 in order to comply with necessary SOP's, job-specific training materials, GMP's, and other manuals.
Basic Computer skills in Microsoft Word, Excel, and Outlook and the 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, such things as calipers, scales, gauges, and other measuring devices.
Ability to demonstrate proficiency in reading equipment drawings.
Ability to work safely with equipment under pressure.
Physical/Safety Requirements:
Must be able to lift and carry up to 70lbs, and push and pull up to 150 lbs.
Extended periods of standing and/or walking.
Extended periods in Grade A, B, C, D production environments.
Use of hands and fingers to manipulate equipment is required.