Production Technician III (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 Production Technician III provides direct support to equipment in the Packaging production area. This support consists of the initial set-up of equipment prior to batch processing, changeover activities between batch processing, and troubleshooting during batch processing. A Production Technician III reports directly to the Finishing Supervisor, works with various cross-functional teams to maximize equipment efficiencies and provide ideas for continuous improvement opportunities. The Production Technician III must fully

support operations on the production floor and communicate effectively with production team members.

The responsibilities :

• Analyze machine / line downtime and efficiency information to respond to operational needs
• Communicate equipment issues to subsequent shifts, Supervisor and appropriate personnel via electronic tech report
• Evaluate and implement improvements to all processes associated with the equipment to increase efficiencies and reduce
• Use all available data (downtime reports, OEE, etc.) to understand and target bottlenecks in the process
• Initiate / complete work orders for equipment related problems
• Provide recommendations and implement solutions to equipment / process challenges
• Ensure all setup and changeover activities are complete and accurate, with an emphasis on achieving target changeover times
• Evaluate changeover parts and ensure that appropriate repairs are made between uses or replacement parts are ordered
• Provide training to Machine Operators for general equipment operation, setup, changeover and troubleshooting
• Work with Finishing Training, Supervisors, Machine Operators, to evaluate and improve SOPs
• Provide support during equipment qualification / validation

Desirable qualifications :

Physical / Safety Requirements :

In return, you'll be eligible for [1] :

Medical & Dental Coverage

Spouse Life Insurance

Paid Holidays

Voluntary Insurance Benefits

Vision Coverage

Workout Facility

[1] Current benefit offerings are in effect through 12 / 31 / 25

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability / handicap status or any other legally protected characteristic.

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