Remote Manufacturing Engineer III - Process & Validation

Pelican Products, Inc.; Maple Grove (MN); Remote; USD 90,000 - 120,000; Full time

Benefits offered by this job

Salary + bonus

Medical, dental, vision

401(k) match

Paid vacation & holidays

Employee Assistance Program

Professional development

Lead global projects

Cross-functional teams

East Coast travel

Career growth

Job summary

Peli BioThermal is hiring a Manufacturing Engineer III in Memphis (Remote). You will provide technical leadership across multiple manufacturing locations, guiding validation, process development, and continuous improvement while ensuring compliance with quality systems.

The role requires a Bachelor's in engineering, 7+ years of experience in regulated manufacturing, IQ/OQ/PQ proficiency, Lean and Six Sigma knowledge, and a willingness to travel up to 50%.

Qualifications

• Bachelor's degree is required; Master's preferred.
• 7+ years of manufacturing engineering experience in a regulated environment.
• Experience leading equipment specification, installation, commissioning, and validation activities (IQ, OQ, PQ).
• Knowledge of Lean Manufacturing, Six Sigma, FMEA, root cause analysis, and structured problem-solving techniques.
• Experience with change control, validation documentation, and regulated quality systems.
• Excellent project management, communication, and leadership skills.
• Ability to travel up to 50%.

Responsibilities

• Lead equipment validation, process development, and continuous improvement across locations.
• Develop and execute IQ/OQ/PQ validation protocols.
• Lead equipment installation, commissioning, and transfers to multiple facilities.
• Partner with Operations, Maintenance, Quality, Engineering, and Supply Chain to resolve challenges.
• Drive Lean and Six Sigma projects to improve quality and efficiency.
• Conduct risk assessments, change control, and process improvement projects.
• Support new product introductions with manufacturing readiness and launches.
• Analyze data to improve throughput, product quality, and reliability.
• Develop manufacturing docs, SOPs, and validation protocols.
• Serve as SME during internal/audits and regulatory inspections.
• Mentor junior engineers and train Operations teams.
• Travel up to 50%.

Skills

Lean Manufacturing

Six Sigma

FMEA

Root cause analysis

Structured problem-solving

Project management

Communication

Leadership

Cross-functional collaboration

Travel readiness

Education

Bachelor's Degree in Mechanical, Manufacturing, Industrial, or related Engineering discipline

Master's Degree

Job description

Peli BioThermal is hiring a Manufacturing Engineer III in Memphis (Remote). You will provide technical leadership across multiple manufacturing locations, guiding validation, process development, and continuous improvement while ensuring compliance with quality systems.

The role requires a Bachelor's in engineering, 7+ years of experience in regulated manufacturing, IQ/OQ/PQ proficiency, Lean and Six Sigma knowledge, and a willingness to travel up to 50%.