Filling Operator, 3rd Shift Weekend

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.

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This role:

The Filling Operator (Operator III) position is responsible for aseptic execution of assigned activities within the Grade A/B manufacturing area; activities shall include current Good Manufacturing Practices (cGMP) compliant gowning, setup and operation of aseptic filling equipment, aseptic movement of components and fill machine equipment, and conformance to Good Documentation Practices (GDP) standards. A Filling Operator will also initiate minor revisions to existing documents and troubleshoot simple processes / equipment failures.  This Filling Operator may be required to cross-train as a support Operator for additional areas.  This position reports to a Manufacturing Supervisor. 

 

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 A/B work areas.  Perform sanitizations in a timely and effective manner in accordance with cGMPs and Simtra procedures, maintaining production schedule.  
• May be required to cross train as a support operator to assist additional manufacturing areas. 
• Maintain organization at all times within the classified areas to ensure equipment segregation, readiness and to prevent any contamination or rejection of batches. 
• Perform routine verification of equipment when unloading autoclaves and setting up aseptic filling machines.   
• Setup and operate aseptic filling equipment for routine aseptic processes, performed with proper aseptic technique to prevent negative safety, identity, strength, purity and quality (SISPQ) impact to the batch.     
• Perform routine operations utilizing aseptic formulation and filling equipment in Grade A/B areas.  
• Perform environmental monitoring; including fingertip, contact, and fallout plates. 
• 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 Shift: Saturday/Sunday 11:00 pm - 9:30am, plus 2 weekdays (either Mon/Tues or Thurs/Fri 11:00pm - 7:30am)

 

The work environment: 

Classified pharmaceutical environment wearing required gowning. Must be able to work safely with materials required