illing Operator/ Formulation/Manufacturing Technician

Company: LanceSoft Inc
Location: Durham
Posted on: March 19, 2023

Job Description:

Job Title: Filling Operator/ Formulation/Manufacturing Technician
Location: Durham, NC, 27712
Duration: 6 Months

Job Description:
The Process Technician position is responsible for the operation of high speed equipment used in the production and packaging of BacT/ALERT bottles and/or preparing and formulating the liquid reagents that fill the finished BacT/ALERT bottle in a cGMP compliant manner.

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• The position may perform or assist in the setup, inspection, preventive maintenance, troubleshooting and cleaning of equipment used throughout the BacT/ALERT Manufacturing and Packaging processes.
  
• Additionally, this individual will be responsible for completing production batches and corresponding documentation for the associated tasks
  
• AQL inspections, reworks and Material reconciliation that goes along with the batch.
  
  
  Production
  
  
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  • Manufacturing & Packaging: Operate high speed manufacturing equipment, in some cases highly automated, using HMI/SCADA interfaces
    
  • Formulation: chemical weighing and reagent formulation
    
  • Execute production activities per approved Manufacturing Directions while maintaining compliance with all job related SOPs
    
    
    Quality
    
    
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    • Ensure that all batch paperwork is completed in an accurate, thorough, and timely manner
      
    • Perform and document all processes and procedures in a timely manner, while maintaining compliance with all company and regulatory agency regulations
      
    • Provide assistance with the review and revision of Manufacturing Directions and SOPs necessary for the manufacture and packaging of product.
      
    • Assist with manufacturing deviation analysis, CAPA actions and other process equipment related quality concerns
      
    • Maintain all work areas in a well-organized, clean and tidy manner at all times in compliance with cGMP requirements
      
      
      Safety
      
      
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      • Comply with all safety policies and procedures at all times
        
      • Appropriately use PPE (Personal Protection Equipment) as required to perform routine and non-routine duties.
        
        
        Other Duties
        
        
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        • Generate reports, charts and KPI's and interpret the data to identify problems, and proceed with proper decision making
          
        • Assist with executing validation protocols associated with manufacturing/packaging equipment and procedures including revalidation as scheduled or required to maintain systems in a validated state
          
        • Perform computer applications
          
        • Perform other duties as assigned by Management
          
          
          Experience
          
          
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          • Minimum of 0-1 years in a regulated production/operations environment
            
            
            Skills
            
            
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            • Certification in Bioworks Program preferred
              
            • For Manufacturing and Packaging - Demonstrated proficiency in the operation of high speed, highly automated, production equipment preferred.
              
              
              For Formulation
              
              
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              • Background in Bulking and/or compounding in food, supplement, cosmetic, medical device, or pharmaceutical chemical formulation is desired.
                
              • Familiarity with measurement scales, mixing, blending, chemical mills and other formulation manufacturing equipment strongly desired.
                
              • Knowledge of and experience in following OSHA regulations (LOTO, electrical safety, etc.) preferred.
                
              • Knowledge of FDA and/or GMP regulations preferred.
                
              • Mechanical background preferred.
                
              • Ability to rapidly learn new procedures and reduce them to practice.
                
              • Must be able to learn, comprehend and demonstrate competency in operating new equipment within a 75-day period of working with a trainer.
                
              • High School diploma or GED equivalent is required
                
              • 1-2 years experience in FDA regulated manufacturing environment and (GMP) Good Manufacturing Practices is desired
                
              • Ability to express ideas clearly (verbal and written) with the ability to work from verbal and/or written instructions, manuals, work orders and specifications
                
              • Ability to perform necessary calculations and complex task sequences in order to meet production requirements
                
              • Attention to detail and the ability to accurately interpret technical documentation are critical
                
              • Ability to perform computer applications including learning and performing SAP transactions
                
              • Ability to routinely lift 20-40 pounds
                
              • Ability to stand for 8-12 hours
                
              • Ability to work overtime as required to cover a 24/7 operation
                

Keywords: LanceSoft Inc, Durham , illing Operator/ Formulation/Manufacturing Technician, Professions , Durham, North Carolina