Preparation Operator (3rd Shift Weekends)

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 Prep Operator (Operator II) will work in and maintain a Grade C/D environment. They will perform routine cleaning and sanitization to help ensure readiness and current Good Manufacturing Practices (cGMP) compliance within the classified and non-classified work areas. Activities shall include cGMP compliant gowning, conformance to Good Documentation Practices (GDP) standards, integrity testing of filters, and cleaning, setup, and sterilization of equipment and components. Ability to operate preparation equipment such as autoclaves, sonicators, depyrogenation ovens, and vial and stopper washers. The Preparation Operator may be required to cross-train as a support Operator for additional areas. This position reports to the Manufacturing Supervisor. 

This position is required to work all designated plant holidays.

3rd shift, Weekends:  Saturday/Sunday 11pm – 9:30am, plus 2 weekdays (either Mon/Tues or Thurs/Fri) 11pm – 7:30am. 

The responsibilities: 

• Understand and follow current Good Manufacturing Practices 
• Perform routine cleanup and sanitizations as assigned by area supervision to maintain cGMP compliance within the Grade C/D work areas 
• Perform sanitizations in a timely and effective manner in accordance with cGMPs and Simtra procedures, maintaining production schedule 
• Maintain organization at all times within the classified areas to ensure segregation, readiness and to prevent any contamination or rejection of batches 
• Compare Lot numbers to ensure correct components are being used for the specified batch 
• Complete calculations to support preparation activities 
• Retrieve and test in-process samples 
• Clean and sample equipment 
• Required to maintain attendance in accordance with the Bloomington Attendance Policy 
• Scheduled weekend overtime will be required 

 

The work environment: 

Classified pharmaceutical environment including wearing required gowning as shown in