Validation Engineer - Grandville Area

We are collaborating with multiple companies in Grandville seeking experienced Validation Engineers. These organizations value long-term fit and are looking for professionals who bring both skill and alignment. By joining our network, you gain access to opportunities tailored to your goals.

• →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 detailed reports, and present findings to cross-functional teams.
• →Investigate and resolve deviations, non-conformances, and out-of-specification results during validation activities.
• →Collaborate with R&D, Quality, and Manufacturing teams to ensure successful technology transfer and product launch.
• →Maintain and update validation documentation, including master validation plans, procedures, and reports.
• →Participate in internal and external audits, providing expert support on validation-related inquiries.

• Bachelor's degree in engineering or a related scientific discipline.
• 3+ years of experience in validation activities within a regulated manufacturing environment (e.g., medical devices, pharmaceuticals, biotech).
• Proven knowledge of GxP regulations (e.g., FDA 21 CFR Part 820, Part 210/211, ISO 13485) and industry best practices for validation.
• Experience in developing and executing validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Strong understanding of statistical methods and their application in validation.

• Experience with statistical process control (SPC) and design of experiments (DOE)
• Familiarity with cybersecurity principles in manufacturing environments
• Certification in Lean Six Sigma (Green Belt or Black Belt)
• Programming skills (e.g., Python, R, VBA) for data analysis and automation

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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.