Manufacturing Engineer III

SHINE Technologies LLC•Janesville, WI

9d•$100,000 - $115,000

About The Position

SHINE Technologies is seeking a Manufacturing Engineer who will work independently and with cross functional teams on complex reliability and continuing improvement projects related to the commercial manufacturing of Lu-177. The base salary range for this position is $100,000 - $115,000 per year plus a comprehensive compensation package. Our salary ranges are determined by role, level, and location.

Requirements

Bachelor’s degree in engineering or equivalent combination of experience and education.
4-7 years of experience supporting manufacturing operations in a GMP-regulated environment.
Experience with improvement methodologies such as Lean manufacturing, Six Sigma, or Root Cause Analysis.
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.

Nice To Haves

Experience working in radiopharmaceutical or nuclear manufacturing environments.
Experience in leading deviations, investigations, CAPA, and change controls.
Experience support or leading technology transfer, new equipment introduction, or line expansions.
Working knowledge of equipment qualification (IQ/OQ/PQ) and validation life cycle.

Responsibilities

Process Optimization:
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.
Troubleshooting & Problem Solving:
Identify and disposition operational issues, including equipment malfunctions, process deviations, and quality concerns.
Resolve issues using a structure 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).
Equipment Support:
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.
Regulatory Compliance:
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.
Conduct risk assessments to identify and mitigate potential hazards associated with manufacturing process.
Project Management:
Lead or contribute to projects related to process improvements or equipment upgrades.
Manage timelines, budgets, and resources to meet project objectives and deadlines.
Collaborate with cross-functional teams (e.g., R&D, manufacturing, quality) to determine qualification or validation requirements.
Documentation & Reporting:
Prepare and review process documentation, standard operating procedures (SOPs), technical reports, and production batch records.
Ensure all manufacturing activities are well-documented and comply with regulatory standards.
Training & Development:
Train production staff on new manufacturing processes, equipment operation and maintenance, and safety protocols.
Foster a culture of compliance and continuous learning within the team.
Safety & Risk Management:
Ensure all processes meet safety and environmental regulations.
Maintain a safe and efficient working environment.