About the position
SHINE Technologies is immediately seeking a Manufacturing Engineer to work independently and with cross functional teams on complex reliability and continuing improvement projects related to the commercial manufacturing of Lu-177. The position involves working the 3rd shift from 9:00pm to 9:00am, Tuesday to Thursday, with a 3rd Shift Premium of $3.00/hour.
Responsibilities
- Analyze and improve existing manufacturing processes to increase productivity, reduce waste, optimize critical process parameters, and ensure consistent product quality.
- Implement Lean manufacturing and Six Sigma methodologies for continuous process improvement.
- Prepare, review, and approve change control requests related to manufacturing processes and ensure proper documentation of any changes.
- Identify and disposition operational issues, including equipment malfunctions, process deviations, and quality concerns.
- Resolve issues using a structured approach, incorporating tools like cost-benefit analysis and decision matrices.
- Conduct risk assessments and develop strategies to mitigate operational risks.
- Collaborate with cross-functional teams to implement corrective and preventive actions (CAPA).
- Oversee the installation, commissioning, and maintenance of manufacturing equipment.
- Write and maintain procedures for the operation of equipment and performance of preventative maintenance to ensure proper calibration, maintenance schedules, and compliance with equipment qualification (IQ, OQ, PQ) standards.
- Ensure all manufacturing processes comply with GMP, FDA, EMA, and other relevant regulatory guidelines.
- Maintain accurate and complete records of all manufacturing activities, including process parameters, equipment maintenance, and deviations.
- Lead or contribute to projects related to process improvements or equipment upgrades.
- Manage timelines, budgets, and resources to meet project objectives and deadlines.
- Prepare and review process documentation, standard operating procedures (SOPs), technical reports, and production batch records.
- Train production staff on new manufacturing processes, equipment operation and maintenance, and safety protocols.
- Ensure all processes meet safety and environmental regulations.
Requirements
- Bachelor’s degree in engineering or equivalent combination of experience and education.
- Experience working in an FDA-regulated and nuclear environments is preferred.
- Experience with improvement methodologies such as Lean manufacturing, Six Sigma, or CAPA.
- Strong desire to learn and be taught about pharmaceuticals and nuclear medicine.
- Willingness to learn and understand new technology, instrumentation, and technical processes.
- Ability to read engineering drawings or schematics.
- Ability to follow written procedures and accurately record test data.
- Ability to wear all proper PPE in order 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.
