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Manufacturing Specialist Sterile Fill

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Argenta

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Location:
United States , Shawnee, Kansas

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Category:
Manufacturing

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

Perform operations in a line team environment to provide high quality pharmaceutical products on time and in the right quantities to customers.

Job Responsibility:

  • Comply with all workplace standards and safety procedures, including Lockout Tagout, Current Good Manufacturing Practices (cGMPs), Occupational Safety and Health Administration requirements (OSHA), Standard Operating Procedures (SOPs), and Company Guidelines
  • Perform equipment setup and changeover activities
  • Act to safely reduce equipment setup and changeover times
  • Initiate and establish equipment operating parameters to maximize production, while meeting all product specifications
  • Meet line Operational Asset Effectiveness requirements per area targets
  • Escalate downtime properly
  • Perform the daily setup and routine operation of the packaging line, including but not limited to bottle in-feed, unscrambler, filler, bottle capper, torquer, labeler, vision systems, weighing systems, bar coding systems, sealers, disassembly/assembly, cleaning, resolving equipment stoppages and jams, and all material handling as trained
  • Perform preventive maintenance tasks as needed and trained
  • Troubleshoot Variable Frequency Drives and Servo Drive systems as trained
  • Inspect packaging components, in-process items, and packaged drug products to assure compliance to specifications, identify any non-conforming item and initiate appropriate actions
  • Palletize both finished and unfinished products and operate motorized and non-motorized material handling equipment
  • Complete, maintain, and update production documentation (both electronic and paper) to perform material movements, material take-outs and yield determinations by following SOPs and utilizing systems as required such as Systems/Applications/Products (SAP), Manufacturing Execution Systems (MES), Electronic Batch Records (EBRs), et al.
  • Take ownership of training and learning to develop high performance competencies such as technical skills, communication skills, and skills to build a collaborative culture (i.e., training team members, motivating, and supporting team members, sharing knowledge to continuously improve the process)
  • Meet the production schedules outlined by line team and/or Supervision
  • Review and approve work output for team members by using validated methods
  • Manage area cleaning requirements including facility, equipment, and Operational Excellence initiatives
  • Perform the functions required for the Bio-Class I clean room sterile filling and sterile filtration of all sterile drug solution products from bulk into final containers
  • This position will also include running the autoclave, terminal sterilizer, preparation of filling equipment and components, and maintaining area logbooks and housekeeping procedures
  • Includes monitoring, trouble shooting, and training for activities of filtration, and filling preparation which include basic understanding of MMI (Man Machine Interface) Systems, CIP (Clean in Place) Systems and SIP (Steam in Place) processes
  • Participate in Sterile Media Fill qualifications for Sterile Filling and maintenance activities
  • Disassemble, clean, reassemble, and prepare all sterile filling product contact equipment and supplies for sterilization
  • Other duties as assigned

Requirements:

  • High School Diploma or GED
  • 2 years manufacturing experience
  • Previous experience using automated inventory systems
  • Previous experience using motorized & non-motorized material handling equipment
  • Demonstrated ability to successfully changeover/set up multiple pieces of packaging/manufacturing equipment and strong troubleshooting skills
  • Good written and verbal communication skills in English
  • Good PC Skills, including use of e-mail, attaching documents to e-mail
  • Previous experience using electronic databases and on-line tools
  • Demonstrate ability to work safely in a production environment
  • Ability to read/interpret/follow instructions regarding workplace documentation
  • Possess a good mathematical aptitude in addition, subtraction, multiplication, division, & metric system
  • Experience in a government regulated, Good Manufacturing Practices (GMP) or standard operating procedures (SOP) environment
  • Must be willing to work overtime as required, based on production demands

Additional Information:

Job Posted:
March 04, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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