Validation Engineer - Traverse City Area

We are working with companies in Traverse City 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.

• →Develop and execute validation protocols for equipment, processes, and software.
• →Perform IQ, OQ, PQ activities and generate comprehensive validation reports.
• →Conduct risk assessments and develop validation strategies in compliance with regulatory requirements.
• →Collaborate with cross-functional teams to ensure successful implementation of validated systems.
• →Investigate deviations and out-of-specification results, implementing corrective and preventive actions.
• →Maintain and update validation documentation throughout the system lifecycle.

• Bachelor's degree in engineering or a related scientific discipline.
• 3+ years of experience in validation within a regulated manufacturing environment (e.g., medical device, pharmaceutical).
• Demonstrated expertise in authoring and executing validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Strong understanding of cGMP, FDA regulations (e.g., 21 CFR Part 820, Part 211), and industry standards for validation.
• Experience with risk-based validation approaches and statistical methods for data analysis.

• Experience with statistical process control (SPC) and design of experiments (DOE).
• Familiarity with data analysis tools (e.g., Minitab, JMP, R, Python).
• Certified Quality Engineer (CQE) or similar professional certification.
• Knowledge of cybersecurity principles as they apply to manufacturing systems.
• Experience with risk management frameworks beyond FMEAs, such as FTA or HAZOP.

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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 https://www.thepivotgroup.org.

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 https://www.thepivotgroup.org. 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.