Process Validation & Integration Engineer Medical Packaging

Vonco Products LLC; Salem Lakes (WI); On-site; USD 90,000 - 120,000; Full time

Job summary

Vonco Products LLC, based in Wisconsin, is seeking an Integration (Process Validation) Engineer to lead validation activities for medical device packaging and related processes. The role collaborates across Operations, Quality, Design Engineering, and customers to ensure compliant manufacturing integration and product introductions.

The successful candidate will develop IQ/OQ/PQ protocols, perform analyses, and drive improvements while maintaining compliance with FDA 21 CFR Part 820, ISO 13485,

Qualifications

• Bachelor’s degree in Engineering or related field; 3+ years in regulated manufacturing.
• Experience with process validation and documentation within FDA/ISO environments.
• Strong writing, communication, and cross-functional collaboration skills.

Responsibilities

• Develop and execute IQ, OQ, and PQ validation protocols and reports.
• Lead validation activities for packaging, sealing, printing, and related processes.
• Perform process capability studies and statistical analysis to support validation.
• Establish process windows, critical parameters, and acceptance criteria.
• Support New Product Introductions and process transfers to production.
• Identify improvements to quality, efficiency, and throughput; lead CAPA activities.
• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, GMP, and customer requirements.
• Support internal, customer, and regulatory audits.

Skills

Statistical analysis

Root cause analysis

Risk management

Documentation

Project coordination

Education

Bachelor’s degree in Engineering

Tools

EQMS systems

IQ/OQ/PQ protocols

Job description

Vonco Products LLC, based in Wisconsin, is seeking an Integration (Process Validation) Engineer to lead validation activities for medical device packaging and related processes. The role collaborates across Operations, Quality, Design Engineering, and customers to ensure compliant manufacturing integration and product introductions.

The successful candidate will develop IQ/OQ/PQ protocols, perform analyses, and drive improvements while maintaining compliance with FDA 21 CFR Part 820, ISO 13485,