Machine Operator - Shift

Simtra Bio Pharma Solutions (Simtra) is a world‑class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre‑filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder‑filled vials and sterile crystallization.

Shift 3

Hours:

10:45PM-6:45AM

• Equipment Operation
  • Follow and execute machine operation according to standard operating procedures (SOPs) and batch record instructions
  • Maximize equipment efficiency during operation, ensuring first pass quality product
  • Periodically check/examine units from good and or reject areas to ensure proper equipment function
  • Challenge equipment and or verification systems according to SOPs or batch record instructions
  • Document all actions performed at the time of performance; assist with verifying various batch record or other equipment steps for teammates
  • Communicate equipment issues to subsequent shifts, Supervisor and appropriate personnel
  • Contact and work with internal resources and or vendors to maintain/improve equipment performance
  • Meet equipment/line efficiency targets by proactively taking action to prevent downtime; work with upstream or downstream team members to help line flow
  • Use and sample printed materials to the batch record by First In First Out (FIFO) machine outputs or reports before, during, or after processing
• Set-up, Tear down, & Changeover
  • Thoroughly clean and clear machines in established target timelines between production operations
  • Perform set‑up and changeover activities independently for assigned machine; assist set‑up and or changeovers on additional equipment when available
  • Verify all set‑up/changeover steps have been completed properly using set‑up checklists
  • Monitor setup and changeover process to ensure completion within target set/changeover time
  • Assist Quality Assurance and or production clearance personnel with clearance of machine
• Machine Troubleshooting
  • Track machine faults and or downtime system data as problems occur; share information with Technician/Maintenance/Engineering support and help recommend appropriate action to correct the equipment issue
  • Clear most faults and re‑start equipment following shutdown with minimal direction or supervision according to SOPs or batch record instructions
  • Assist with completing work orders for equipment related problems
  • Provide recommendations and implement solutions to equipment/process challenges
  • Utilize all available information and support groups to resolve problems in a timely manner with documentation and follow up to problems with inadequate/defect material
• Continuous Improvement, Training, and Safety
  • Train peers and Relief Machine Operators for general equipment operation, setup and changeover
  • Work with Finishing Training, Supervisors, Machine Operators, etc. to update/improve SOPs
  • Immediately address any safety or training deficiencies discovered by you or your team mates; notify appropriate levels of management as necessary
• Equipment Qualification
  • Provide support to equipment qualification/validation
  • Develop SOPs for equipment implementation
  • Work with Tech Services, Engineering, Maintenance and Production to ensure smooth transition to production use direct support to test components and equipment
• Other
  • Required to maintain attendance in accordance with the Bloomington Attendance Policy
  • Scheduled weekend overtime will be required
  • Visual acuity 20/20 with or without corrective vision and ability to pass color blind test
  • Ensure all safety practices are followed and keep area clean and clear of hazards

Controlled pharmaceutical environment including wearing long sleeves, safety toe shoes, gloves and safety glasses. Ability to work in a team environment on a variety of automated packaging equipment.

• Ability to work independently
• Good communication skills
• Good documentation skills, including legible handwriting
• Good interpersonal skills
• Basic computer skills
• Basic math skills
• Knowledge of standard operating…