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Preparation Operator (2nd Shift)

Bloomington, IN 47402

Posted: 02/12/2024 Employment Type: Direct Hire/Perm Job Category: Production Job Number: 597935 Is job remote?: No Country: United States

Job Description


Target Pay Rate: 18.70/hr **salary will be commensurate with experience 

Job Description: 

The Prep Operator (Operator II) will work in and maintain a Grade C/D environment. They will perform routine cleaning and sanitization to help ensure readiness and current Good Manufacturing Practices (cGMP) compliance within the classified and non-classified work areas. Activities shall include cGMP compliant gowning, conformance to Good Documentation Practices (GDP) standards, integrity testing of filters, and cleaning, setup, and sterilization of equipment and components. Ability to operate preparation equipment such as autoclaves, sonicators, depyrogenation ovens, and vial and stopper washers. The Preparation 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: 
  • Understand and follow current Good Manufacturing Practices 
  • Perform routine cleanup and sanitizations as assigned by area supervision to maintain cGMP compliance within the Grade C/D work areas 
  • Perform sanitizations in a timely and effective manner in accordance with cGMPs and client procedures, maintaining production schedule 
  • Maintain organization at all times within the classified areas to ensure segregation, readiness and to prevent any contamination or rejection of batches 
  • Compare Lot numbers to ensure correct components are being used for the specified batch 
  • Complete calculations to support preparation activities 
  • Retrieve and test in-process samples 
  • Clean and sample equipment 
  • Required to maintain attendance in accordance with the Bloomington Attendance Policy 
  • Scheduled weekend overtime will be required 

Work Environment:  Classified pharmaceutical environment including wearing required gowning as shown in attached document.  Occasional work with water and pharmaceutical product while wearing applicable Personal Protective Equipment.  Must be able to work safely with materials required to produce pharmaceutical products, including chemicals, compounds, glassware and sanitization solutions. 

Qualification Requirements:  To perform this job successfully an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals to perform the essential functions: 
  • Ability to work independently 
  • Good communication skills 
  • Good documentation skills, including legible handwriting 
  • Good interpersonal skills 
  • Basic computer skills, including ability to navigate enterprise software (ie Pilgrim, JDE, etc) 
  • Basic math skills 
  • Knowledge of aseptic manufacturing practices 
  • Knowledge of standard operating procedures, specifications, and job-specific training materials 
  • Requires the 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. 

Education and Experience:  High school diploma or GED required, 6 months of previous Pharmaceutical or Manufacturing experience preferred. 

Language Skills:  Must be able to understand, speak, read and write English in order to comply with necessary SOP’, job-specific training materials, GMP’s, and other manuals. 

Physical Demands 
  • Occasional (0-33%) Sitting, climbing stairs and ladders, overhead reaching and/or lifting, balancing, kneeling, crouching, crawling, operating controls
  • Lifting and carrying up to 53 lbs
  • Pushing up to 105 lbs 
  • Pulling up to 22 lbs
  • Frequent (34-66%) Standing, walking, reaching forward, stooping, object handling, fingering, fine hand coordination simple and firm hand grasping  
  • Lifting and carrying up to 34.25 lbs
  • Pushing and pulling up to 15 lbs 

Additional Requirement:  Final candidates for Prep Operator will be required to pass a post offer/pre-employment job placement examination which will test the physical capabilities to perform the essential functions of the job. 
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About Bloomington, IN

Discover exciting job opportunities in Bloomington, Indiana! Nestled in the heart of the Hoosier State, Bloomington offers a vibrant community, a thriving arts scene with venues like the Buskirk-Chumley Theater and the Eskenazi Museum of Art, and a bustling downtown area filled with charming shops and unique restaurants serving up delicious farm-to-table cuisine. Home to Indiana University, a top-tier educational institution, Bloomington provides endless growth opportunities and a welcoming atmosphere for professionals looking to advance their careers. Don't miss the chance to be part of this dynamic city, explore our job listings today and kickstart your career in Bloomington!

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