Job Description

Validation Engineer

Company Overview We are an expanding medical device manufacturer currently tripling our facility footprint and growing our customer base. We are seeking a dedicated Validation Engineer to lead validation deliverables and manage process and equipment qualifications.

Position Details

• Job Title: Validation Engineer
• Compensation: $80,000 - $120,000 / year (commensurate with experience)
• Schedule: Monday - Friday, 7:00 AM - 5:00 PM (On-site; flexibility required for up to 60 hours per week based on project demands)
• Southern Milwaukee Area

Job Summary

This position is responsible for all validation engineering functions, with a primary focus on IQ, OQ, PQ activities and regulatory compliance. You will work cross-functionally with R&D, Manufacturing, Quality, and Regulatory teams to manage validation master list activities, establish documentation, and support production improvements.

Key Responsibilities

• Develop and execute IQ, OQ, and PQ protocols for equipment, processes, utilities, analytical methods, and software.
• Author, review, and manage Validation Master Plans, SOPs, Protocols, Work Instructions, and risk analysis documentation (FMEAs).
• Ensure all validation practices and documentation comply with FDA 21 CFR Part 820 and ISO 13485 standards.
• Interface with R&D during design transfer, supporting Design of Experiments (DOE) and statistical analysis of measurements.
• Support production validation, equipment modifications, and qualification/requalification of sterilization processes.
• Monitor validation KPIs, manage timelines, and communicate project status to internal teams and external customers.

Qualifications

Required:

• 2 to 4 years of validation engineering experience in the medical device industry (ISO 13485 / 21 CFR 820).
• Hands-on experience with IQ/OQ/PQ execution, equipment validation, and regulatory documentation.
• Associate degree in a relevant technical field required; Bachelor's degree preferred.

Preferred:

• Experience with Six Sigma, process capability statistics, SPC, and AQL.
• Familiarity with ISO 14971 (Risk Management) and ISO 11135 / ISO 11137 (Sterilization) standards.
• Relevant certifications (CQA, CQE, CQM).

Key Attributes:

• Strong attention to detail and ability to work in a fast-paced, regulated manufacturing environment.
• Effective written and verbal communication skills.

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