Process Engineer - Packaging

Simtra Bio Pharma 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  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.

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:
We are looking for a Process Engineer I - Packaging that is responsible for developing, implementing, and optimizing automated inspection and packaging processes to improve efficiency, quality, and productivity. This engineer will work closely with cross-functional teams to identify areas for process improvement, troubleshoot issues, and ensure compliance with safety and regulatory standards in pharmaceutical automated inspection & packaging areas. This position is 100% onsite at the Bloomington facility and reports directly to the Process Engineering Manager.

The responsibilities
:

• Demonstrate a strong ownership for the equipment and processes in the filling or packaging areas you support
• Implement process improvement projects that enhance efficiency, improve quality and reduce costs for automated inspection & packaging processes
• Identify and implement new equipment and tooling as needed in support of new product launches
• Develop user requirements (URS), technical specification and design specifications for new automated inspection & packaging equipment and/or upgrades to existing equipment
• Author and execute protocols to include commissioning, qualification, and validation activities (FAT, SAT, IQ and OQ) for packaging systems
• Participates in collaborations with external engineering firm or OEM in feasibility assessments, concept design, basic design and detail design
• Develop and maintain project schedules using MS Project
• Collaborate with suppliers to source processing and/or packaging equipment parts to ensure quality standards are met
• Provide technical support and training to operations and maintenance automated inspection & packaging equipment
• Continuously interacts with all functions and levels of management ensuring effective, ongoing communications across teams and stakeholders
• Support with complex sites investigation of key safety and production issues and events and work on the identification and implementation of CAPA plans to address such events and prevent recurrence

The qualifications:

• BS degree in Engineering…