Process Validation & Integration Engineer Medical Packaging

Vonco Products LLC; Salem Lakes (WI); On-site; USD 85,000 - 110,000; Full time

Job summary

Vonco Products LLC in Trevor, Wisconsin, is seeking an Integration (Process Validation) Engineer to lead and support process validation and manufacturing integration for medical device packaging and related processes.

You will collaborate with Operations, Quality, Design Engineering, and customers to drive NPI, validation activities, and continuous improvement while maintaining regulatory compliance.

Qualifications

• Bachelor’s degree in Engineering or related field.
• 3+ years in regulated manufacturing.
• Experience with process validation.
• Knowledge of IQ/OQ/PQ methodologies.
• Familiarity with FDA 21 CFR Part 820 and ISO 13485.
• Strong technical writing skills.

Responsibilities

• Lead IQ, OQ, and PQ validation protocols and reports.
• Lead validation for flexible film converting, RF welding, heat sealing, pouch manufacturing, printing, and labeling operations.
• Perform process capability studies and statistical analysis to support validation.
• Establish process windows, critical process parameters, and acceptance criteria.
• Support new product introductions (NPI) from concept to production.
• Identify and implement process improvements focused on quality and throughput.
• Lead root cause investigations and corrective actions related to process performance.
• Ensure compliance with FDA 21 CFR Part 820 / QMSR, ISO 13485, GMP, and customer requirements.
• Support audits, customer visits, and regulatory inspections.

Skills

Process validation

IQ/OQ/PQ

Regulatory compliance

Statistical analysis

Root cause analysis

Technical writing

Project management

Education

Bachelor’s degree in Engineering

Tools

EQMS systems

Job description

Vonco Products LLC in Trevor, Wisconsin, is seeking an Integration (Process Validation) Engineer to lead and support process validation and manufacturing integration for medical device packaging and related processes.

You will collaborate with Operations, Quality, Design Engineering, and customers to drive NPI, validation activities, and continuous improvement while maintaining regulatory compliance.