Process Engineer

Simtra BioPharma Solutions•Bloomington, IN

2d•Onsite

About The Position

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.

Requirements

Bachelors Degree in engineering
three years pharmaceutical experience as process engineer
Experience working in aseptic manufacturing environment
Interfacing with PLC, HMI, Vision Systems and Building Management systems
Ability to use enterprise software commonly used in pharmaceutical manufacturing operations
Supporting filling machines involving sterile drug products, vile filling processes, lyophilization equipment, and associated manufacturing systems
Reading mechanical and electrical drawings
Knowledge of AutoCAD or equivalent component design knowledge

Responsibilities

Lead end-to-end project management for pharmaceutical engineering initiatives, overseeing specifications, budgeting, procurement, scheduling, installation, validation, and delivery of upgrades, repairs, and turnkey systems.
Provide hands-on manufacturing and regulatory support through equipment troubleshooting, IQ/OQ validation, investigations and CAPA authorship, change control and work order ownership, and SME participation in regulatory, client, and internal audits.