Software Validation Engineer

Position: Software Validation Engineer Location: Plymouth, MN (Onsite)

Experience: 5–8 years Hire Type: Contract

Job Description

We are seeking an experienced Software Validation Engineer to support validation activities in a regulated environment. The ideal candidate will have strong expertise in software testing, compliance standards, and quality management systems within the medical device or pharmaceutical domain.

Responsibilities

• Develop and execute software validation plans , requirements, risk assessments, protocols, and reports.

• Perform software testing in compliance with regulatory and industry standards.

• Collaborate with cross-functional teams and subject matter experts to define intended use and validation strategies.

• Ensure validation deliverables align with SDLC methodologies , QMS , and organizational SOPs.

• Author and maintain validation documentation including plans, protocols, and summary reports.

• Apply Computerized System Validation (CSV) approaches for non-product applications.

• Provide compliance support with FDA regulations (21 CFR Part 11, Part 820) , ISO 13485 , EU MDR , and GAMP 5 guidelines.

Requirements

• Bachelor’s degree in Computer Science, Information Technology, Electronics Engineering , or a related field.

• 5–8 years of experience in software validation within medical device, pharmaceutical, or regulated healthcare industries .

• Strong knowledge of SDLC , validation planning, risk management, and quality assurance principles.

• Hands-on experience with software development and verification tools .

• Solid understanding of QMS, GAMP 5, 21 CFR Part 11, ISO 13485, EU MDR , and related standards.

• Proficiency in preparing validation documentation as per SOPs or work instructions.