Capping Operator, 3rd 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 Capping Operator (Operator II) position supports aseptic filling operations by staging and delivering components, conducting in-process testing, operating capping equipment, conducting inspections of filled units, batch count reconciliation, and terminal sterilization in conformance with current Good Manufacturing Practices and Good Documentation Practices (cGMP/GDP) standards. The Capping Operator will also initiate minor revisions to existing documents and troubleshoot simple processes / equipment failures. The Capping Operator may be required to cross-train as a support Operator for additional areas. This position reports to the Manufacturing Supervisor. 

 

The responsibilities: 

• Understand and follow current Good Manufacturing Practices (cGMP) 
• Operate automated terminal sterilizers 
• Perform product weight verification 
• Perform routine cleanup, line clearances, and sanitizations as assigned by area supervision to maintain cGMP compliance within the work areas 
• Perform sanitizations in a timely and effective manner in accordance with cGMPs and Baxter procedures, maintaining production schedule 
• Maintain organization at all times within the classified areas to ensure equipment and product segregation, readiness and to prevent any contamination or rejection of batches 
• Perform routine verification of equipment and instruments 
• Setup and operate capping equipment 
• Assist in the training and development of other team members 
• Required to maintain attendance in accordance with the Bloomington Attendance Policy 
• Scheduled weekend overtime will be required 

 

The work environment: 

Classified pharmaceutical environment wearing required gowning as shown in attached document.  Must be able to work safely with materials required to produce pharmaceutical products, includin