Direct Hire
Description for Lead Process Engineer:
This lead engineer role for process and equipment design and will provide influence into getting processes developed and turned over to manufacturing operations. This is a fast-paced product development cycle to help cure some of life-threatening forms of cancer and is looking for team members that fit well into this environment.
Responsibilities for Lead Process Engineer:
Collaborate with multiple process development teams to support translation of small-scale processes to design requirements and specifications for full-scale production systems and processes
Lead process development and process validation activities to support launch of commercial manufacturing
Establish robust manufacturing processes and monitoring systems for full-scale production
Collaboratively develop equipment and process commissioning plans
Lead start-up and commissioning of equipment and processes
Troubleshoot equipment problems and develop corrective actions
Collaboratively develop and execute equipment qualifications (IQ, OQ, PQ)
Develop SOPs, batch records, and technical documents
Assists other projects and departments as required
Some travel may be required
Requirements for Lead Process Engineer:
BS in Chemical/Mechanical/Nuclear Engineering, Chemistry, Radiochemistry or Physics with 7+ years of relevant experience
Demonstrated experience with manufacturing within FDA GMP regulatory requirements is highly desired.
Experience or knowledge of nuclear process equipment and instrumentation is desired
Willingness to learn and understand new technology, instrumentation and technical processes
Ability to read from engineering drawings or schematics
Ability to follow written procedures and accurately record test data
Ability to work safely within an industrial and radiation environment
