Process Validation & Integration Engineer – Medical Packaging

A Hiring Company; Burlington (WI); On-site; USD 70,000 - 85,000; Full time

Job summary

A Hiring Company is seeking an Integration (Process Validation) Engineer to lead and support process validation for medical device packaging and flexible film converting. The role ensures processes are developed, validated, transferred, and maintained in compliance with FDA 21 CFR Part 820 and ISO 13485.

You will collaborate with Operations, Quality, Design Engineering, and customers on NPI, equipment qualifications, and ongoing validation activities, while supporting audits and customer

Qualifications

• Bachelor’s degree in Engineering or related field.
• 3+ years in a regulated manufacturing environment.
• Experience with process validation in regulated manufacturing.
• Working knowledge of IQ/OQ/PQ, statistics, RCA, and risk mgmt.
• Knowledge of FDA 21 CFR Part 820 and ISO 13485.
• Strong technical writing and documentation skills.

Responsibilities

• Develop and execute IQ, OQ, and PQ validation protocols and reports.
• Lead validation for film converting, RF welding, heat sealing, pouch printing/labeling.
• Perform process capability studies and statistical analysis.
• Establish process windows and acceptance criteria.
• Support NPI from concept to production.
• Identify process improvements to quality and throughput.
• Lead root cause investigations and corrective actions.
• Ensure FDA/ISO/GMP compliance and customer quality requirements.
• Support audits and regulatory inspections.
• Lead cross-functional project activities for validation and implementation.

Skills

Process validation

IQ/OQ/PQ

Regulatory knowledge

Technical writing

Root cause analysis

Education

Bachelor’s degree in Engineering

Tools

EQMS systems

Statistical software

Job description

A Hiring Company is seeking an Integration (Process Validation) Engineer to lead and support process validation for medical device packaging and flexible film converting. The role ensures processes are developed, validated, transferred, and maintained in compliance with FDA 21 CFR Part 820 and ISO 13485.

You will collaborate with Operations, Quality, Design Engineering, and customers on NPI, equipment qualifications, and ongoing validation activities, while supporting audits and customer