Validation Engineer - Kalamazoo Area

We partner with manufacturers across Kalamazoo seeking Validation Engineers who want more than a lateral move. These companies hire intentionally, and we connect them with professionals ready for roles that fit.

• →Develop and execute validation protocols (IQ, OQ, PQ) for manufacturing equipment, processes, and systems.
• →Perform risk assessments and generate validation plans in compliance with regulatory requirements (e.g., FDA, ISO).
• →Analyze validation data, write comprehensive reports, and present findings to cross-functional teams.
• →Investigate and resolve deviations or non-conformances identified during validation activities.
• →Support the lifecycle management of validated systems, including revalidation and change control.
• →Collaborate with engineering, quality, and production teams to ensure successful project execution and regulatory compliance.
• →Maintain and update validation documentation to ensure audit-readiness and adherence to internal procedures.

• Bachelor's degree in Engineering, Life Sciences, or a related technical field.
• 3+ years of experience in validation within a regulated manufacturing environment (e.g., medical device, pharmaceutical, biotechnology).
• Strong understanding of GxP, FDA regulations (e.g., 21 CFR Part 820, Part 211, Part 11), and ISO standards (e.g., ISO 13485).
• Proven experience in developing, executing, and reviewing validation protocols and reports (IQ, OQ, PQ) for equipment, processes, and software.
• Proficiency in statistical methods and data analysis for validation activities.

• Additional certifications or training

Validation Specialist, CSV Engineer, Computer System Validation Engineer, Process Validation Engineer, Equipment Validation Engineer, Software Validation Engineer, Quality Engineer - Validation, QA Validation Engineer, Validation Consultant, Senior Validation Engineer

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.