SHINE Technologies is a seeking a Process Engineer for their Systems & Manufacturing Division. The Process Engineer is a leader in the field of process and equipment design and will provide leadership to develop processes and equipment 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, diagnostic medical imaging isotopes and SHINE’s Phase 3 recycling and reusing spent nuclear fuel.
Duties and Responsibilities of the Process Engineer include:
- 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 design, development and validation activities to support launch of commercial manufacturing
- Design, implement, and optimize processes for the manufacturing of nuclear pharmaceutical products, ensuring adherence to quality standards and regulatory requirements
- Process could include Liquid-liquid separation, liquid-solid separation, material extraction, and packaging of the final product.
- Collaboratively develop equipment and process commissioning plans
- Lead start-up and commissioning of equipment and processes
- Troubleshoot equipment and manufacturing problems along with developing corrective actions
- Collaboratively develop and execute equipment qualifications (IQ, OQ, PQ)
- Develop and maintain comprehensive process documentation, including SOPs, batch records, process flow diagrams, and validation protocols.
- Identify areas of improvement in current production processes, driving initiatives to enhance productivity, efficiency, and safety
- Assists other projects and departments as required
- Some travel may be required
- Overtime may sometimes be necessary to complete required work assignment with little or no advance notice
- BS in Chemical Engineering, Mechanical Engineering, 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
- Six Sigma or Process Improvement experience 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
Eligibility for employment is conditioned on the applicant’s ability to qualify for access to information subject to U.S. Export Controls. Additionally, applicant’s eligibility may be conditioned based upon meeting the Nuclear Regulatory Commission requirements for access to Safeguards Information, which typically requires a pre-employment drug screen, fingerprinting and criminal background check.
SHINE values diversity in all its forms as a critical component of innovation, which is fundamental to our success. Every member of the SHINE community benefits from the talents and experiences of our peers, from the mutual respect we exercise, and from the responsibility we take for our actions.
SHINE Technologies is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.