Chemical Process Engineer
SHINE Technologies is seeking a Chemical Process Engineer. The Chemical Process Engineer is a leader in the field of process and equipment design and will provide leadership to get processes and equipment developed so they can be implemented in volume production. This is a fast-paced product development cycle for the manufacturing of radiopharmaceutical products to help cure life-threatening forms of cancer.
Duties and Responsibilities of the Chemical Process Engineer:
- Collaborate with multi-disciplinary development teams to support translation of small-scale R&D (Research & Development) processes into design requirements and component 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
Requirements
- BS in Chemical/Mechanical/Nuclear Engineering, Chemistry, Radiochemistry or Physics with 5+ 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, chromatography, cryogenics, and vacuum is preferred
- Experience doing HAZOPS, FMEAs, instrument outputs and design calculations such as mass balance, heat transfer is preferred
- 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
- Some travel may be required