Process Engineer

Benefits

Additional Information

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: We are looking for a Process Engineer (level depends on experience) that is responsible for developing, implementing, and optimizing manufacturing 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 the pharmaceutical aseptic manufacturing or automated inspection & packaging areas. This position is 100% onsite at the Bloomington facility and reports directly to the Sr. Manager, Engineering & Maintenance. The responsibilities: Demonstrates a strong ownership for the equipment and processes in the filling or packaging areas Implement process improvement projects that enhance efficiency, improve quality, and reduce costs for aseptic filling processes, lyophilization, or inspection & packaging processes Develop user requirements (URS), technical specification and design specifications for new processing (aseptic filling, lyophilization, equipment preparation, formulation) and/or 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 Collaborates with external engineering firms 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 on aseptic processing equipment or inspection & packaging equipment Interact with all functions and levels of management, ensuring effective, ongoing communication across teams and internal/external stakeholders Support with complex site investigation of key safety and production issues and events and work on the identification and implementation of CAPA (Corrective and Preventive Action) plans to address such events and prevent recurrence Required qualifications: BS degree in Engineering (Chemical, Mechanical, Electrical, Packaging, Pharmaceutical, Biomedical), or a related technical field 1+ years of experience in aseptic processes or inspection & packaging engineering in the pharmaceutical industry (level hired for depends on years of experience) 0-2 years of experience (Level I) 2-5 years of experience (Level II) 5-8 years of experience (Level III/Sr.) 8+ years of experience (Level IV/Principal) Knowledge of the basic principles in aseptic processing and/or packaging engineering best practices Must be able to lead and execute engineering projects Strong understanding of packaging materials, processing, and testing methods Experience with PLC, HMI, Vision Systems and Building Management systems Strong oral and written communication skills Must be able to read mechanical, electrical, and P&ID drawings AutoCAD or equivalent component design knowledge Advanced proficiency in Microsoft Office Suite (Word, Excel, and Outlook) Experience and the ability to use enterprise software (examples include: JDE, Microso

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