Lyophilization Technician (Weekend AM Shift)

Simtra BioPharma Solutions•Bloomington, IN

4d•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.

Requirements

High school diploma or GED required
Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)
Ability to stand and walk for extended periods of time
Ability to lift up to 50 pounds
Ability to push/pull heavy wheeled objects (ie: tanks, carts, pallet jacks, etc.)
Must be able to perform overhead work (ie: sanitizing walls and ceilings)
Must be able to gown qualify for Grade A/B areas and perform routine operations in clean room environments
Utilize applicable personal protective equipment, including safety shoes/toe caps, gloves, eye protection, heat resistant wear, respirator, and hearing protection
Use of hands and fingers to manipulate office equipment is required

Nice To Haves

minimum 6 years of related manufacturing experience preferred
Associates degree, preferably in a Science or Maintenance/Engineering field, with a minimum of 4 years related manufacturing experience.
Knowledge of PLCs preferred
Experience with refrigeration, compressors, condensers, HVAC preferred
Ability to complete lyophilization and refrigeration training program
Experience in a related technical field or discipline.
Demonstrated ability to troubleshoot technical equipment issues/failures
Ability to read and follow engineering prints and drawings preferred

Responsibilities

Monitors each lyophilizer during operation via appropriate checks and documentation.
Performs all aspects of lyophilization preparation such as Clean in Place (CIP), Steam in Place (SIP), and leak tests.
Troubleshoots or repairs mechanical failures / faults with the lyophilization systems.
Coordinates with the Maintenance, Engineering, Chemistry, Quality, R&D, Technical Services, and outside vendors to implement new client cycles / cycle updates, mechanical readiness of the lyophilizers, and troubleshooting of the lyophilization systems.
Trains other departments on lyophilization related activities.
Proactively evaluates system functionality to identify and prevent possible system issues that may result in equipment downtime.
Identifies system malfunctions that require follow up and appropriate communication across shifts and departments to ensure proper equipment readiness.
Assists with process/equipment validation.
Ability to cross-train in other Manufacturing or Maintenance areas and train others on production-related equipment.