Direct HireDescription for Manufacturing Engineer:
Bleeding edge pharma co. that has new particle accelerators onsite for medical isotope production (MRI/imaging).
The Manufacturing Engineer is a hands-on position responsible for the transfer of new isotopes processing into manufacturing, on-going production support, validation, and process improvement of complex isotopes processes. This position involves a strong focus towards process, process improvement and day to day support of production lines to meet quality and production goals. All duties and responsibilities will be done in compliance with cGMP, FDA, and DHS regulations.
Responsibilities for Manufacturing Engineer:
Direct involvement with the manufacturing process development linked to Isotopes.
Hands on direct production support of isotopes production processes once released to production.
Troubleshooting and disciplined problem-solving activities to resolve current manufacturing issues.
Develop and maintain cGMP compliant process work instructions, batch production records, reports, and plan documentation.
Requirements for Manufacturing Engineer:
Bachelor’s Degree in Engineering, (Chemical or Mechanical preferred), from an accredited college or university and three or more years of experience as a Manufacturing or Process Engineer; or equivalent combination of education and experience. Experience executing process validation and documentation activities (IQ/OQ/PQ) is required. Strong experience with FDA regulations, cGMP regulations, and pharmaceutical/medical device industry is preferred.