Manufacturing Engineer III

We’re Hiring:
Manufacturing Engineer III

Location:

Indianapolis, IN

Company:
Peli Bio Thermal

Peli Bio Thermal 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 Bio Thermal 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 Bio Thermal, 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.

• 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.

• Competitive salary with annual bonus opportunity.
• Comprehensive medical, dental, and vision coverage.
• 401(k) with company match.
• Paid vacation,…