Manufacturing Engineer III

Overview

Location:

Indianapolis, IN. Company:
Peli Bio Thermal.

About Us:

Peli Bio Thermal offers a wide range of temperature-controlled packaging and service solutions for the global life sciences industry. Our products help ensure that delicate biological materials arrive intact and effective, even under challenging exterior environments. We are focused on developing innovative products to meet the needs of the global life sciences industry and offer services and software to support end-to-end temperature-controlled packaging asset management.

At Peli Bio Thermal, your work has a real-world impact. Youll be part of a team driven by innovation, craftsmanship, and a 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.

• 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.

• 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%.

• 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.

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. Regular opportunities to share feedback with leadership and structured performance evaluations help ensure 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