Engineering/ Manufacturing Tech

Job Type

Full-time
Description
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.
Duties and Responsibilities:
Specific duties and responsibilities of the Manufacturing Engineer III include, but are not limited to:

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.
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.

Preferred Qualifications:
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.
Employees must be able to perform the essential functions of the position satisfactorily. If requested, reasonable accommodations will be made to enable employees with disabilities to perform the essential functions of this job, absent undue hardship to the company.
Working Conditions and Physical Effort:
Work involves moderate exposure to unusual elements, such as extreme temperatures, dirt, dust, fumes, smoke, unpleasant odors, and/or loud noises.
Work environment involves some exposure to hazards or physical risks, which require following basic safety precautions.
Moderate physical activity. Requires handling of average-weight objects up to 40 pounds or standing and/or walking for more than four (4) hours per day.
The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor. Management reserves the right to change, rescind, add or delete the duties and responsibilities of positions within this job at any time.
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.

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