Production Technician, Packaging (3rd Shift)

Simtra BioPharma Solutions•Bloomington, IN

3h•Onsite

About The Position

Simtra BioPharma 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 at Simtra. We 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. This role: The Production Technician III provides direct support to equipment in the Packaging production area. This support consists of the initial set-up of equipment prior to batch processing, changeover activities between batch processing, and troubleshooting during batch processing. A Production Technician III reports directly to the Finishing Supervisor, works with various cross-functional teams to maximize equipment efficiencies and provide ideas for continuous improvement opportunities. The Production Technician III must fully support operations on the production floor and communicate effectively with production team members.

Requirements

High school diploma or GED required with proven mechanical aptitude.
Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: Microsoft Dynamics, Veeva, Trackwise, etc.)
Must be able to lift, push/pull, and carry up to 50 pounds
Required to stand for up to 8 hours per day, including constant standing for 2 hours at a time
Must be able to lift 20 pounds overhead
Use of hands and fingers to manipulate equipment is required

Nice To Haves

Associate’s degree in a technical field

Responsibilities

Analyze machine/line downtime and efficiency information to respond to operational needs
Communicate equipment issues to subsequent shifts, Supervisor and appropriate personnel via electronic tech report
Evaluate and implement improvements to all processes associated with the equipment to increase efficiencies and reduce
Use all available data (downtime reports, OEE, etc.) to understand and target bottlenecks in the process
Initiate/complete work orders for equipment related problems
Provide recommendations and implement solutions to equipment/process challenges
Ensure all setup and changeover activities are complete and accurate, with an emphasis on achieving target changeover times
Evaluate changeover parts and ensure that appropriate repairs are made between uses or replacement parts are ordered
Provide training to Machine Operators for general equipment operation, setup, changeover and troubleshooting
Work with Finishing Training, Supervisors, Machine Operators, to evaluate and improve SOPs
Provide support during equipment qualification/validation