Filling and Capping Operator

Overview

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 components and 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 Dutiesand Responsibilities (theseareprimaryresponsibilitiesoftheroleandtheincumbent 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 tomaintainc
  
  GMP compliance within the Cleanroomwork areas.
  
  Perform sanitizations ina timelyand effective mannerin accordance withc
  
  GMPsand
  
  Simtraprocedures,maintaining production schedule.
• May berequiredto cross train as a support operator toassistadditionalmanufacturing 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 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 in Cleanroomareas.
• Perform environmental monitoring;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

• High school diploma or GED required, 6 months of previous
  
  Pharmaceutical or Manufacturing experience preferred.
• Must be able to understand, speak,readand write Englishin order tocomply with necessary SOP’s, job-specific training materials, GMP’s, and other manuals.
• Basic Computer skillsin
  
  Microsoft
  
  Word,Excel,and Outlookandtheabilitytouseenterprisesoftware(examples include:
  
  Veeva, D365, Blue Mountain, etc.)
• Musthavetheabilitytoworkeffectivelyina”handsonenvironment”capableoftroubleshootingcomplex equipmentandsystems
• 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 todemonstrateproficiencyin reading equipment drawings.
  
  Ability to work safely with equipment under pressure.

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