Validation Engineer - Fremont Area

Job Description:

Validation Engineer | Fremont, MI

Salary Range: $79,000 - $119,000 depending on experience

Are you a skilled professional with a passion for excelling in validation engineer? The Pivot Group Network, a West Michigan manufacturing-focused recruiting group, is dedicated to building meaningful connections in the manufacturing community. We are collaborating with companies in Fremont seeking experienced Validation Engineers.

We are building our network of talent in this field across West Michigan and the broader manufacturing region Pivot Group Network serves. Our partner companies may or may not have an immediate opening for this exact role today, but we actively look for skilled professionals in the regions where they operate. If there is alignment now or in the near future, we reach out.

The Opportunity

We collaborate with manufacturing companies in the Fremont region seeking Validation Engineers. These employers partner with us because they want real insight into candidates-not just resumes. By joining our network, you gain access to roles worth considering.

Key Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for manufacturing equipment, processes, and systems.
• Perform risk assessments and generate validation plans to ensure compliance with regulatory requirements (e.g., FDA, ISO).
• Analyze validation data, write reports, and present findings to cross-functional teams.
• Investigate deviations, implement corrective actions, and ensure proper documentation of all validation activities.
• Maintain and update validation master plans, procedures, and related documentation.
• Collaborate with engineering, quality, and production teams to support new product introductions and process improvements.
• Conduct periodic reviews of validated systems to ensure continued compliance and effectiveness.

Recommended Qualifications

• Bachelor's degree in engineering or a related scientific discipline.
• 3+ years of experience in validation within a regulated manufacturing environment (e.g., medical devices, pharmaceuticals).
• Strong understanding of GxP regulations and industry standards (e.g., FDA 21 CFR Part 820, ISO 13485).
• Proven experience with validation methodologies including IQ, OQ, PQ for equipment, processes, and software.
• Excellent technical writing skills for creating and reviewing validation protocols and reports.

Bonus Qualifications

• Additional certifications or training

Job Titles That Should Apply

Validation Engineer, Senior Validation Engineer, Principal Validation Engineer, CSV Engineer, Computer System Validation Engineer, Process Validation Engineer, Equipment Validation Engineer, Software Validation Engineer, Test Engineer, Verification Engineer, Quality Engineer, QA Engineer, Quality Assurance Engineer, Regulatory Affairs Specialist, Compliance Engineer, Validation Specialist, Validation Lead, Validation Manager

Why The Pivot Group Network

The Pivot Group Network was founded by manufacturing professionals who've been on both sides of the hiring process. Our clients are strategic-they partner with us because they want real insight into their roles and the people filling them, not a stack of resumes. We focus on match-driven placements built around what actually matters: Commute, Compensation, Culture, and Career trajectory. Learn more at ;br>
If you're ready to take the next step in your career and connect with a firm that values fit over speed, we invite you to reach out at The Pivot Group Network offers resources to support your search-market insights, resume feedback, and interview preparation. As our partnerships grow, we'll reach out with opportunities aligned with your goals. Thank you for considering this approach to career advancement.

Required Skills:
Technical Writing
Resume
Data
Offers
Access
Support
Regulatory Requirements
Assurance
Compliance
Salary
Hiring
Partnerships
Corrective Actions
Recruiting
Compensation
Validation
Reviews
Manufacturing
Quality Assurance
Writing
Regulations
Preparation
Software
Documentation
Engineering
Training

Salary Package:
$ 79,000.00 - 119,000.00 (US Dollar)