Drug Product MSAT Engineer
Regeneron · Limerick, Munster, IE
Within this role The Drug Product (DP) Manufacturing Science and Technology (MSAT) Engineer supports equipment selection, CMO selection strategy, management...
Job description
Within this role The Drug Product (DP) Manufacturing Science and Technology (MSAT) Engineer supports equipment selection, CMO selection strategy, management of equipment qualification and process validation activities, and will be hands-on solving issues during technology transfer and cGMP start-up. The MSAT team establishes best practices for technical support of cGMP drug product manufacturing operations. The Engineer also provides floor support during operations of off-site manufacturing, reviews process data to ensure operational consistency after the processes are successfully transferred and provides support for investigations. As an Drug Product MSAT Engineer, a typical day might include the following: To be considered for this role you should have a BS/BA in engineering and 2 years of experience in a pharmaceutical / biologics cGMP environment or equivalent combination of education and experience. Travels to contract manufacturers or business partners, as required, up to 25-50%. - Providing drug product manufacturing process knowledge for new product introduction, technology transfer, process troubleshooting and issue resolution - Acting as the technical lead, with the supp...