Formulation & Preparation Operator

Summary:

TheFormulation & PreparationOperator (Operator II& III)positionsupports aseptic filling operations bystaging and delivering components, conducting in-process testing,weighing materials, formulation of product, and conducting in-process testing,filtration, cleaning and sanitization, sterilization ofequipment,batch reconciliation,compliant gowning, setup and operation ofparts washer, autoclaves,and tank cleaningin 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 positionreportsto 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,andsanitizations asassigned 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.

• Compare Lot numbers to ensure correct components are being used for the specified batch

• Complete calculations to support preparationand formulationactivities

• Retrieveand test in-process samples

• Clean, Sterilize,and sample equipment

• Setupand operateautocalves, parts washers,tank cleaning, and formulation stationsinCleanroomareas.

• Assistin the training and development of other team members

• Required tomaintainattendancein accordance withthe Bloomington Attendance Policy

• Scheduled weekend overtimemayberequired

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 tothe manufacturingoperations 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 carryupto70lbs, andpush and pullup to150 lbs.

• Extendedperiodsofstandingand/orwalking

• ExtendedperiodsinGradeA,B,C,Dproductionenvironments

• Useofhandsandfingerstomanipulateequipmentisrequired