Manufacturing Engineer III

Peli BioThermal; Indianapolis (IN); On-site; USD 95,000 - 125,000; Full time

Benefits offered by this job

Annual bonus

Medical, dental, vision insurance

401(k) with company match

Paid vacation and holidays

Wellness programs

Professional development and training

Global engineering projects

Travel opportunities (East Coast)

Job summary

Peli BioThermal in Indianapolis, IN is seeking a Manufacturing Engineer III to lead equipment validation, process development, and continuous improvement across multiple sites, ensuring compliance with quality and regulatory standards.

The role partners with Operations, Maintenance, Quality, and Supply Chain; drives Lean and Six Sigma initiatives; supports new product introductions; and travels up to 50% to facilities.

Qualifications

• Bachelor's Degree in Mechanical, Manufacturing, Industrial, or related Engineering discipline required.
• 7+ years of manufacturing engineering experience within a regulated manufacturing environment.
• 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.

Responsibilities

• Lead manufacturing process development, equipment implementation, and process optimization for temperature-controlled packaging products.
• Develop and execute equipment and process validation protocols (IQ/OQ/PQ).
• Lead equipment installation, commissioning, qualification, and manufacturing process transfers across facilities.
• Collaborate with Operations, Maintenance, Quality, Engineering, and Supply Chain to resolve complex manufacturing challenges.
• Drive continuous improvement initiatives using Lean and Six Sigma methodologies.
• Oversee risk assessments, change control, and process improvement projects to boost quality and reliability.
• Support new product introductions by ensuring manufacturing readiness and successful production launches.
• Analyze manufacturing data to improve throughput, quality, and performance.
• Maintain manufacturing documentation, work instructions, validation protocols, and SOPs.
• Serve as SME during audits and regulatory inspections.
• Mentor junior engineers and provide training to Operations and Maintenance teams.
• Travel up to 50% to manufacturing facilities and service centers.

Skills

Leadership

Lean Manufacturing

Six Sigma

Equipment validation

Process development

Continuous improvement

Project management

Cross-functional collaboration

Education

Bachelor's Degree in Mechanical/Manufacturing/Industrial Engineering

Master's Degree preferred

Tools

IQ/OQ/PQ validation

Regulatory compliance

Job description

Indianapolis, IN, 915 Airtech Pkwy, Plainfield, Indiana, United States of America

Job Description

Posted Monday, July 13, 2026 at 4:00 AM

We're Hiring: Manufacturing Engineer III

Location: Indianapolis, IN
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

Compensation & Benefits:
Our compensation reflects the cost of labor across severalU.S. geographic markets. Base pay is one part of our total compensation package and is determined within a range. This provides the opportunity to progress as you grow and develop within a role. The annual U.S. pay range for this positionis listed below. Paywithin this range varies by work locationand may also depend on your qualifications, job-related knowledge, skills,and experience. Your recruiter can share more about the specific salary range for the job location during the hiring process. We also offer a comprehensive package of benefits, including paid time off, 10 paid holidays per year, medical/dental/vision insurance, company-paid life and disability plans, and matching 401k to eligible employees.

Pelican Products, Inc. is an equal employment opportunity employer.All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

Indianapolis, IN, 915 Airtech Pkwy, Plainfield, Indiana, United States of America