Manufacturing Engineer III

W2 Contract

Pay Rate: $48 - $55 per hour

Location: Janesville, WI - Onsite Role

Job Summary:

We are 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.

Duties and 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 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).
• 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 the 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.

Requirements and Qualifications:

• 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.

Preferred Qualifications:

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

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

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