Lead Process Engineer

Job Requisition: 6772

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

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