Senior Manufacturing Engineer — Validation & CI, Multi-Site

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

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.