Job Description

The Filling & Capping Operator (Operator II & III) position supports aseptic filling operations by staging and delivering components, conducting in-process testing, operating fill line equipment, conducting inspections of filled units, batch count reconciliation, compliant gowning, setup and operation of aseptic filling equipment, aseptic movement of componentsand terminal sterilization 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 cGMPs 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.

• Setup and operate aseptic filling equipment for routine aseptic processes, performed with proper aseptic technique to prevent negative safety, identity, strength, purity and quality impact to the batch.

• Perform routine operations utilizing aseptic formulation and filling equipment in Cleanroom areas.

• Perform environmental monitoring; including fingertip, contact, and fallout plates.

• 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

• Successful operator qualification/media fill performance required to achieve increased operator levels

JobRequirements(Education,ExperienceandQualifications):

• 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.

PhysicalSafetyRequirements

• Must be able to lift and carry up to 50 lbs, and push and pull up to 50 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