Validation Engineer- #259214

Medix™; Milwaukee (WI); In loco; USD 80.000 - 120.000; Tempo pieno

Descrizione del lavoro

Medix, a growing medical device manufacturer in the Milwaukee area, seeks a Validation Engineer to lead IQ/OQ/PQ activities and manage validation master plans. You will collaborate with R&D, Manufacturing, Quality and Regulatory teams to ensure compliant validation deliverables and drive production improvements.

The role requires 2–4 years of validation experience in medical devices, strong documentation skills, and a Bachelor’s (preferred) or Associate degree.

Competenze

• Experience executing IQ, OQ, PQ protocols and generating corresponding documents.
• Ability to manage Validation Master Plans, SOPs, Protocols, Work Instructions, and risk analyses.
• Familiarity with FDA 21 CFR Part 820 and ISO 13485 compliance requirements.

Mansioni

• 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 analyses (FMEAs).
• Ensure validation practices and documentation comply with FDA 21 CFR Part 820 and ISO 13485 standards.
• Interface with R&D during design transfer and support DOE and statistical analysis.
• Support production validation and qualifications of sterilization processes.
• Monitor validation KPIs and communicate status to teams and customers.

Conoscenze

IQ/OQ/PQ execution

Regulatory documentation

Validation master plans

Regulatory compliance

Formazione

Associate degree

Bachelor's degree preferred

Strumenti

FMEA

DOE

SPC

Descrizione del lavoro

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.

• 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.

Key Attributes

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