Job Description

Job Title: Computer Systems Validation Engineer
Client: Medical Device Manufacturing Company
Location: Maple Grove, MN 55311
Duration: 6 Months Contract
Focus Area: FDA-regulated Medical Device Software/Systems Validation
Position Overview
The Computer Systems Validation Engineer will be responsible for validating software and equipment in compliance with FDA regulations and company policies. This role will ensure that systems meet strict quality, compliance, and documentation standards. The ideal candidate will have strong technical expertise in validation processes, SDLC, and regulatory compliance, with experience in medical device manufacturing.
Key Responsibilities

• Define, develop, and maintain comprehensive specifications for equipment/software (e.g., PLCs, Visual Basic apps, databases, SCADA applications, FDA-regulated systems).
• Develop and review validation/qualification protocols, ensuring compliance with FDA requirements and QSR regulations.
• Execute validation and qualification protocols, record results, and manage documentation via Change Requests.
• Provide project estimates independently and review estimates for junior engineers.
• Perform project lead activities on small to large-scale validation/qualification projects.
• Ensure consistency and quality of validation work through peer reviews, mentoring, and training of Engineer I's and II's.
• Support audits and regulatory inspections by providing accurate documentation and validation evidence.
• Drive compliance with 21 CFR Part 11 (electronic records/e-signatures) and other FDA guidelines.
• Influence cross-functional engineering initiatives and contribute to defining departmental best practices.

Required Qualifications

• Bachelor's Degree in an Engineering discipline.
• 5-9 years of direct experience in software/equipment validation within a regulated environment.
• Strong background in medical device manufacturing and compliance documentation.
• Hands-on experience with SDLC (System Development Life Cycle).
• Excellent organizational, verbal, and written communication skills.
• Proficiency in MS Office tools.
• Ability to manage multiple priorities, with high attention to detail.
• Strong interpersonal skills and a collaborative, team-oriented mindset.

Preferred Qualifications

• Prior experience in an FDA-regulated industry.
• Experience supporting audits and working with regulatory bodies.
• Prior quality role experience ensuring compliance with industry standards.
• Practical knowledge of 21 CFR Part 11 (electronic records/electronic signatures).

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Skills Required