Validation Engineer | DeWitt, MI

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

Are you a seasoned professional with a passion for excelling in validation engineer? The Pivot Group is committed to fostering meaningful relationships and supporting community growth. We are collaborating with leading companies in DeWitt seeking Validation Engineers to lead and enhance their operations.

The Opportunity

We are working with companies in DeWitt that are adding Validation Engineers to their teams. These organizations value quality over speed in hiring. By connecting with us, you position yourself for opportunities that align with what you're looking for.

Key Responsibilities

• Develop and execute validation plans and protocols for manufacturing processes, equipment, and systems.
• Perform IQ, OQ, and PQ (Installation Qualification, Operational Qualification, Performance Qualification) activities.
• Document validation activities, including deviations, investigations, and change controls.
• Analyze validation data and prepare comprehensive validation reports.
• Ensure compliance with regulatory requirements (e.g., FDA, GMP) and internal quality standards.
• Collaborate with R&D, Engineering, and Manufacturing teams to ensure successful process and product validation.
• Troubleshoot and resolve validation-related issues.
• Maintain validation documentation and support audits.

Recommended Qualifications

• Bachelor's degree in Engineering or a related scientific discipline.
• 2+ years of experience in a regulated manufacturing environment (e.g., GMP, ISO 13485).
• Proven ability to write and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Strong understanding of FDA regulations, cGMP principles, and quality management systems.
• Proficiency in statistical analysis and risk management methodologies (e.g., FMEA).
• Excellent technical writing skills for creating clear and concise validation documentation and reports.

Bonus Qualifications

• - Experience with statistical process control (SPC) software and analysis.
• - Familiarity with automated test equipment (ATE) development.
• - Knowledge of lean manufacturing principles and their application in validation.
• - Project management certification (e.g., PMP).

Job Titles That Should Apply

Validation Specialist, Test Engineer, Quality Control Engineer, Product Validation Engineer, Software Validation Engineer, Hardware Validation Engineer, Process Validation Engineer, Systems Validation Engineer, Compliance Engineer, Verification Engineer, Technical Validator, Commissioning Engineer, Release Engineer, Test Automation Engineer, Functional Tester, Performance Tester

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.