Senior Technical Writer – Radioisotope Processing Systems – Madison, WI

This position will lead the creation of production process documentation, as related to the development of novel radioisotope processing systems, within the Radioisotope Engineering Processing Team. This documentation will be in the form of operator Work Instructions, Batch Production Records and other associated production procedures. All associated documentation will be updated throughout the development, verification and validation processes, as related to systems used in the production of pharmaceuticals products. This position also involves the development of production equipment service and maintenance procedures and manuals, which include calibration, preventative maintenance, troubleshooting and repair processes. All projects and duties will be completed in compliance with applicable cGMP, FDA, and all other regulatory agencies standards.

We are seeking candidates with a Bachelor’s or Technical Degree in Engineering or Science and eight or more years of experience in an FDA regulated environment; or equivalent combination of education and experience. Authoring technical systems documentation, including manufacturing processes, within a medical device/pharmaceutical industry preferred.

If you are interested in applying for this position, please forward your resume and salary history to hr@northstarnm.com with the position title in the subject line.