Filling and Capping Operator

TheFilling &Capping Operator (Operator II& III) position supports aseptic filling operations by staging and delivering components, conducting in-process testing, operatingfill lineequipment, conducting inspections of filled units, batch count reconciliation,compliant gowning, setup and operation of aseptic filling equipment, aseptic movement of components and terminal sterilization in conformance with current Good Manufacturing Practices and Good Documentation Practices (cGMP/GDP) standards. The Operator will alsoinitiateminor revisions to existing documents and troubleshoot simple processes / equipment failures. The Operator maybe requiredto cross-train as a support Operator foradditionalareas. This position reports to the Manufacturing Supervisor.

EssentialDutiesandResponsibilities(theseareprimaryresponsibilitiesoftheroleandtheincumbent will perform other duties as assigned):

• Understand and follow current Good Manufacturing Practices(GMP)

• Understand and follow current GoodDocumentationPractices(GDP)

• Perform routine cleanup, line clearances,and sanitizations as assigned by area supervision tomaintaincGMP compliance within theCleanroomwork areas.Perform sanitizations ina timelyand effective mannerin accordance withcGMPsandSimtraprocedures,maintainingproduction schedule.

• May berequiredto cross train as a support operator toassistadditionalmanufacturing areas.

• Maintain organization at all timeswithin the classified areas to ensure equipment segregation, readiness and to prevent any contamination or rejection of batches.

• Perform routine verification of equipmentand instruments.

• Setup andoperateaseptic filling equipment for routine aseptic processes, performed with proper aseptictechniqueto prevent negative safety, identity, strength,purityand quality impact to the batch.

• Perform routine operationsutilizingaseptic formulation and filling equipment inCleanroomareas.

• Perform environmentalmonitoring;including fingertip, contact, and fallout plates.

• Assistin the training and development of other team members

• Required tomaintainattendancein accordance withthe Bloomington Attendance Policy

• Scheduled weekend overtimemayberequired

• Successfuloperatorqualification/mediafillperformancerequiredto achieve increased operator levels

Job Requirements (Education, Experience and Qualifications):

• High school diploma or GEDrequired, 6 months ofpreviousPharmaceutical or Manufacturing experience preferred.

• Must be able to understand, speak,readand write Englishin order tocomply withnecessary SOP's, job-specific training materials, GMP's, and other manuals.

• Basic Computer skillsinMicrosoftWord,Excel,andOutlookandtheabilitytouseenterprisesoftware(examples include:Veeva, D365, Blue Mountain, etc.)

• Musthavetheabilitytoworkeffectivelyina"handsonenvironment"capableoftroubleshootingcomplex equipmentandsystems

• Competency inoperation 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 todemonstrateproficiencyin reading equipment drawings.Ability to work safely with equipment under pressure.

Physical / Safety Requirements

• Mustbe abletoliftand carryupto50lbs, andpush and pullup to 50 lbs.

• Extendedperiodsofstandingand/orwalking

• ExtendedperiodsinGradeA,B,C,Dproductionenvironments

• Useofhandsandfingerstomanipulateequipmentisrequired