Lyophilization Technician (2nd Shift)

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.

 

Why join Team Simtra? Because we:

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.

 

 

 

This role:

The Lyophilization Technician is primarily responsible for the preparation of lyophilizers, execution / use of the automated loading and unloading system, and appropriate control and monitoring of the lyophilization cycle. Secondary responsibilities include cross-training in other Manufacturing departments on other production-related equipment and processes. This position reports to the Lyo Supervisor.

The 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.

Desirable qualifications:

• High school diploma or GED required with a 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
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)

 Physical / safety requirements:

• 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 saf