Filling Operator (3rd Shift)
927 S Curry Pike Bloomington, IN 47402 Bloomington, IN 47402 US
Job Description
Target Pay Rate: 20.55/hr **salary will be commensurate with experienceÂ
Job Description:Â
The Filling Operator (Operator III) position is responsible for aseptic execution of assigned activities within the Grade A/B manufacturing area; activities shall include current Good Manufacturing Practices (cGMP) compliant gowning, setup and operation of aseptic filling equipment, aseptic movement of components and fill machine equipment, and conformance to Good Documentation Practices (GDP) standards. A Filling Operator will also initiate minor revisions to existing documents and troubleshoot simple processes / equipment failures. This Filling Operator may be required to cross-train as a support Operator for additional areas. This position reports to a Manufacturing Supervisor.Â
Essential Duties and Responsibilities:Â
- Understand and follow current Good Manufacturing PracticesÂ
- Perform routine cleanup and sanitizations as assigned by area supervision to maintain cGMP compliance within the Grade A/B work areas. Perform sanitizations in a timely and effective manner in accordance with cGMPs and Simtra procedures, maintaining production schedule. Â
- May be required to cross train as a support operator to assist additional manufacturing areas.Â
- Maintain organization at all times within the classified areas to ensure equipment segregation, readiness and to prevent any contamination or rejection of batches.Â
- Perform routine verification of equipment when unloading autoclaves and setting up aseptic filling machines.  Â
- Setup and operate aseptic filling equipment for routine aseptic processes, performed with proper aseptic technique to prevent negative safety, identity, strength, purity and quality (SISPQ) impact to the batch.    Â
- Perform routine operations utilizing aseptic formulation and filling equipment in Grade A/B areas. Â
- Perform environmental monitoring; including fingertip, contact, and fallout plates.Â
- Assist in the training and development of other team membersÂ
- Required to maintain attendance in accordance with the Bloomington Attendance PolicyÂ
- Scheduled weekend overtime will be requiredÂ
Work Environment:  Classified pharmaceutical environment wearing required gowning. Must be able to work safely with materials required to produce pharmaceutical products, including chemicals, compounds, glassware and sanitization solutions.  Must be able to occasionally (1-33% of the time) work in a confined/clustered work space.Â
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:Â
- Ability to work independentlyÂ
- Good communication skillsÂ
- Good documentation skills, including legible handwritingÂ
- Good interpersonal skillsÂ
- Basic computer skillsÂ
- Basic math skillsÂ
- Knowledge of aseptic manufacturing practicesÂ
- Knowledge of standard operating procedures, specifications, and job-specific training materialsÂ
- Requires the operations 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 devicesÂ
Education and Experience:  High school diploma or GED required, 6 months of previous Pharmaceutical or Manufacturing experience preferred.Â
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.Â
Physical DemandsÂ
- Occasional (1-33%)
- Sitting, climbing stairs and ladders, balancing, kneeling, operating controls
- Lifting and carrying up to 70 lbs
- Pushing and pulling up to 35 lbs
- Frequent (34-66%)
- Standing, walking, reaching forward and overhead, stooping, crouching,Â
- Lifting and carrying up to 50 lbs
- Constant (67-100%)
- Object handling, fingering, fine hand coordination, simple hand grasping, firm hand graspingÂ
Additional Requirement:  Final candidates for Filling 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.Â
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