Manufacturing Engineer - 3rd Shift

JOB REQUIREMENTS: 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. Shift: Tuesday - Thursday

9:00pm - 9:00am 3rd Shift Premium - \$3.00/hour The base salary range

for this position is \$97,000/year-\$130,000/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 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.

\*\*\*\*\* OTHER EXPERIENCE AND QUALIFICATIONS: 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. \*\*\*\*\* APPLICATION INSTRUCTIONS: Apply Online:

https://recruiting.paylocity.com/recruiting/jobs/Apply/3145633/SHI E-Technologies-LLC/3rd-Shift-Manufacturing-Engineer