Organizations create new CGMP design certification program

A key issue facing pharmaceutical manufacturers operating in the United States is the need for highly skilled chemical engineers who are well versed in regulatory requirements mandated by federal agencies including the Food and Drug Administration. Unfortunately, many chemical engineering degree programs do not feature a comprehensive regulatory curricula that matches to current industry need. To address this, Cleveland State University has partnered with Xellia Pharmaceuticals to create a Current Good Manufacturing Practices (CGMP) design certification program that provides future workers with the skills necessary to meet workforce demand.

¡°Xellia recently opened a manufacturing facility in Bedford, Ohio and has been actively recruiting engineers to assist with production ramp-up,¡± notes Niels Lynge Agerbaek, General Manager for Xellia Cleveland. ¡°We realized that there was a lack of workforce understanding of the regulatory requirements that are essential to drug manufacturing. We did not have the ability to create a full service training program on our own so looked to partner with an institution to enhance the educational programming that already existed.¡±

¡°CSU continually investigates opportunities to improve our degree programs to better meet the needs of industry, and this opportunity was a chance to provide additional skills that will make our graduates more valuable to Xellia and numerous other pharmaceutical manufacturers,¡± says Joanne Belovich, chair of the Department of Chemical and Biomedical Engineering at CSU.

Xellia Pharmaceuticals¡¯ developed a seven-week course that offered instruction in a host of regulatory topics including architectural design, high purity water systems, and sterile manufacturing, while also providing tours of current manufacturing operations and an opportunity to interact with engineers working in the field. Xellia¡¯s engineers and managers taught the course and Belovich worked with the student chapter of the American Institute of Chemical Engineers and department staff to recruit participants and organize the events. Over 60 students completed the spring edition of the course and received certification. CSU and Xellia Pharmaceuticals plan to offer it again next year and hope to open it up to additional majors on campus.

¡°This partnership allowed our company to address a specific workforce need and identify talented students for future employment opportunities,¡± says Joseph Yurko, a CSU chemical engineering alum who serves as an associate project lead at Xellia. ¡°It also assisted CSU in providing additional professional training and development for their students that will make them more employable in multiple facets of the pharmaceutical industry. It truly is a win-win.¡±

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