Manufacturing Engineer III

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

We're Hiring: Manufacturing Engineer III

Location: Memphis, TN - Remote

Company: Peli BioThermal

About Us

Peli BioThermal offers the widest range of temperature-controlled packaging and service solutions to the global life sciences industry. The company’s products ensure that delicate biological materials arrive intact and effective, despite exterior environments. Peli BioThermal is dedicated to developing innovative products designed to fulfil the complex needs of the global life sciences industry. The company’s customers benefit from its extensive expertise in ensuring that temperature stability is maintained throughout the distribution chain. The company also offers a complete portfolio of services and software to support end-to-end temperature-controlled packaging asset management.

At Peli BioThermal, your work has a real-world impact. You’ll be part of a team driven by innovation, craftsmanship, and the shared belief that when the mission is critical, failure isn’t an option. If you’re ready to build something that makes a difference, be part of a team that protects what matters most.

What You’ll Do

As a Manufacturing Engineer III, you'll provide technical leadership across multiple manufacturing locations by leading equipment validation, process development, continuous improvement initiatives, and new product implementation while ensuring compliance with quality and regulatory requirements.

• Lead manufacturing process development, equipment implementation, and process optimization for temperature-controlled packaging products.
• Develop and execute equipment and process validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Lead equipment installation, commissioning, qualification, and manufacturing process transfers across multiple facilities.
• Partner with Operations, Maintenance, Quality, Engineering, and Supply Chain teams to resolve complex manufacturing and equipment challenges.
• Drive continuous improvement initiatives using Lean Manufacturing, Six Sigma, and structured problem-solving methodologies.
• Lead engineering risk assessments, change control activities, and process improvement projects to improve quality, efficiency, and reliability.
• Support new product introductions by ensuring manufacturing readiness, validation, and successful production launches.
• Analyze manufacturing data and develop solutions that improve throughput, product quality, and operational performance.
• Develop and maintain manufacturing documentation, work instructions, validation protocols, and standard operating procedures (SOPs).
• Serve as the engineering subject matter expert during internal audits, customer audits, and regulatory inspections.
• Mentor junior engineers and provide technical guidance and training to Operations and Maintenance teams.
• Travel up to 50% to manufacturing facilities, service centers, suppliers.

What We’re Looking For

• Bachelor's Degree in Mechanical, Manufacturing, Industrial, or related Engineering discipline required.
• Master's Degree preferred.
• 7+ years of manufacturing engineering experience within a regulated manufacturing environment.
• Demonstrated experience leading equipment specification, installation, commissioning, and validation activities (IQ, OQ, PQ).
• Strong understanding of manufacturing processes, process optimization, and continuous improvement methodologies.
• Experience leading capital equipment projects from concept through implementation.
• 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 collaborate effectively with cross-functional and global teams.
• Willingness and ability to travel up to 50%.

Preferred Qualifications

• Experience supporting pharmaceutical, medical device, biotechnology, cold chain, or other regulated manufacturing environments.
• Experience working with ISO, GMP, GDP, or similar quality systems.
• Experience partnering with Operations and Maintenance teams to improve manufacturing performance.
• Experience supporting multi-site manufacturing operations.
• Knowledge of passive temperature-controlled packaging technologies.

What’s In It For You

Join a company that truly values its employees! We offer a relaxed and casual work environment, a strong commitment to giving back to communities, and a focus on employee satisfaction. With regular opportunities to share feedback with leadership and structured performance evaluations, we ensure that your voice is heard and your growth is supported.

• Competitive salary with annual bonus opportunity
• Comprehensive medical, dental, and vision coverage
• 401(k) with company match
• Paid vacation, holidays, and wellness programs
• Employee Assistance Program
• Professional development and leadership training opportunities
• Opportunities to lead global engineering projects with real business impact
• Work alongside talented engineers and cross-functional teams across multiple manufacturing sites
• Travel throughout our East Coast operations to support manufacturing excellence and continuous improvement
• Career growth within a growing global life sciences organization