Validation Engineer - Ludington Area

Validation Engineer | Ludington, MI

Salary Range: $74,000 - $113,000 depending on experience

Are you a dynamic leader with a passion for excelling in validation engineer? The Pivot Group is dedicated to building meaningful connections and supporting community growth. We are collaborating with leading companies in Ludington seeking experienced Validation Engineers to drive results.

The Opportunity

We collaborate with manufacturing companies in the Ludington 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 and processes.
• Prepare and review validation reports, deviation reports, and change control documents.
• Ensure compliance with regulatory requirements (e.g., FDA, EMA) and internal quality standards.
• Perform risk assessments for new or modified equipment and processes.
• Troubleshoot and investigate validation failures and deviations.
• Maintain validation documentation and ensure its integrity and traceability.
• Collaborate with cross-functional teams (e.g., Engineering, Manufacturing, Quality Assurance) to support validation activities.
• Participate in internal and external audits related to validation.

Recommended Qualifications

• Bachelor's degree in Engineering (e.g., Electrical, Mechanical, Chemical) or a related technical field.
• Proven experience in validation processes within a regulated manufacturing environment (e.g., FDA, GMP, ISO).
• Strong understanding of validation principles, including IQ, OQ, PQ, and CSV.
• Proficiency in developing and executing validation protocols and reports.
• Experience with GxP documentation and regulatory compliance.
• Familiarity with statistical analysis for validation data interpretation.

Bonus Qualifications

• - Experience with statistical process control (SPC) software and methodologies.
• - Familiarity with lean manufacturing principles and their application in validation.
• - Proficiency in data analysis and visualization tools (e.g., Tableau, Power BI).
• - Experience with automated testing frameworks or scripting languages (e.g., Python, VBA).
• - Certification in relevant quality management systems (e.g., ASQ Certified Quality Engineer).

Job Titles That Should Apply

Test Engineer, Software Test Engineer, Automation Test Engineer, QA Automation Engineer, Validation Specialist, Product Validation Engineer, Systems Validation Engineer, Process Validation Engineer, Clinical Validation Engineer, Verification Engineer, Software Verification Engineer, Test Automation Engineer, Quality Assurance Tester, Software Quality Engineer, Test Automation Specialist, Performance Test Engineer, Load Test Engineer, Functional Test Engineer, Regression Test Engineer, Release Engineer, Release Test Engineer, Compliance Engineer, Regulatory Affairs Specialist

Why Pivot Group

The Pivot Group 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.

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. The Pivot Group 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.