Validation Engineer - Paw Paw Area

We are working with companies in Paw Paw 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, and PQ activities for new and modified manufacturing systems.
• →Analyze data and generate comprehensive validation reports.
• →Conduct risk assessments and develop mitigation strategies for manufacturing processes.
• →Ensure compliance with cGMP, FDA regulations, and industry standards.
• →Troubleshoot validation discrepancies and implement corrective actions.
• →Collaborate with cross-functional teams on new product introductions and process improvements.

• Bachelor's degree in Engineering, Life Sciences, or a related technical field.
• 3+ years of experience in validation activities within a regulated manufacturing environment (e.g., medical device, pharmaceutical, biotech).
• Proven experience with GxP regulations, FDA 21 CFR Part 11, Part 820, and relevant industry standards (e.g., ISO 13485).
• Demonstrated expertise in developing and executing validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Strong understanding of statistical methods for data analysis and validation.
• Experience with risk assessment tools and methodologies (e.g., FMEA).

• Experience with statistical process control (SPC) and data analysis tools (e.g., Minitab, JMP).
• Familiarity with automation systems and software validation in a manufacturing context (e.g., SCADA, DCS, PLCs).
• Certified Quality Engineer (CQE) or similar professional certification.
• Knowledge of cybersecurity principles as they apply to validated systems.
• Experience with risk management methodologies (e.g., FMEA, PHA) in a validation context.

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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.