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.

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement  hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

The Machine Operator works within the Finishing/Packaging Complex. They ensure maximum equipment efficiency to meet client demand and expectations. They contribute to creating an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product. Machine Operators will support Manual Inspection and Packaging operations when necessary. This position reports to the Finishing Supervisor.

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 Trouble shooting
  • 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…