Process Engineer
SHINE Medical Technologies
SHINE Technologies is seeking a Process Engineer who will play a critical leadership role in the development, scale-up, and optimization of manufacturing processes for therapeutic radiopharmaceutical products used to help treat life-threatening forms of cancer. The Process Engineer ensures that all processes meet output, quality, cost, and compliance goals in a highly regulated, fast-paced environment.
The base salary range for this position is $92,000-$130,000 plus a comprehensive compensation package. Our salary ranges are determined by role, level, and location.
Duties and Responsibilities of the Process Engineer:
- Lead the design, development, and validation of manufacturing processes compliant with FDA cGMP regulations.
- Translate R&D-scale procedures into robust, scalable production processes and equipment requirements.
- Develop process flow diagrams and critical process parameters.
- Lead equipment selection, installation, and collaboratively develop qualifications (IQ, OQ, PQ) and start-up activities.
- Develop, author, and maintain SOPs, batch production records, process specifications, and technical documentation.
- Conduct troubleshooting and implement corrective actions to improve system reliability and process robustness.
- Identify, analyze, and resolve process bottlenecks to optimize productivity and product quality.
- Implement metrics and monitoring systems to drive continuous process improvements.
- Propose upgrades and modifications to improve operational efficiency, cost-effectiveness, safety, and reduce waste.
- Partner with Quality Assurance and Regulatory Affairs to ensure manufacturing processes meet all compliance and validation requirements.
- Work closely with Research & Development teams to refine processes and support technology transfer activities.
- Lead or contribute to HAZOP, FMEA, and risk assessments to support safe and compliant operations.
- Bachelor's degree in Chemical, Mechanical or Nuclear Engineering, Chemistry, Radiochemistry, or Physics.
- 5+ years of process engineering experience in a GMP-regulated manufacturing environment.
- Experience with nuclear process equipment, chromatography, and/or vacuum systems.
- Familiarity with risk assessment tools such as HAZOP, FMEA, and performing design calculations (e.g., mass balance, heat transfer).
- Six Sigma, Lean Manufacturing, or related process improvement certification.
- Demonstrated experience with process validation (IQ, OQ, PQ) and GMP documentation.
- Ability to read and interpret engineering drawings, P&IDs, technical schematics, follow written procedures, and accurately record test data.
- Strong analytical and problem-solving skills with attention to detail.
- Willingness and ability to work safely in a radiological environment.
- Some travel may be required
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.