Validation Engineer - Lansing Area

We are collaborating with multiple companies in Lansing 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, execute, and review validation protocols and reports (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).
• →Collaborate with cross-functional teams (e.g., R&D, Quality, Manufacturing) to define validation strategies and acceptance criteria.
• →Investigate and resolve deviations and non-conformances encountered during validation activities.
• →Maintain and update validation documentation, including procedures, master plans, and summaries.
• →Provide technical expertise and guidance on validation principles and regulatory expectations to project teams.
• →Support internal and external audits by providing validation documentation and responding to 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).
• Strong understanding of GxP regulations (e.g., FDA 21 CFR Part 820, ISO 13485) and industry validation standards.
• Proven experience in developing and executing validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Familiarity with statistical methods for data analysis and process capability studies.

• Experience with Computer System Validation (CSV) in an FDA-regulated environment.
• Familiarity with GAMP 5 guidelines.
• Knowledge of statistical methods for data analysis and sampling plans.
• Experience with risk-based validation approaches.
• Certified Quality Engineer (CQE) or similar professional certification.

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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.