Validation Engineer - Plainwell Area

We partner with manufacturers across Plainwell 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, execute, and review validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• →Perform risk assessments and generate validation plans to ensure compliance with regulatory requirements.
• →Analyze validation data, generate reports, and present findings to cross-functional teams.
• →Investigate and resolve deviations, non-conformances, and out-of-specification results during validation activities.
• →Collaborate with engineering, quality, and production teams to integrate validation requirements into new and existing systems.
• →Maintain validation master plans, schedules, and documentation in an organized and compliant manner.
• →Support internal and external audits by providing validation documentation and expertise.

• 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, biotech).
• Strong understanding of GxP, FDA regulations (e.g., 21 CFR Part 820, Part 211, Part 11), and international standards (e.g., ISO 13485).
• Proven experience in developing, executing, and reviewing validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Proficiency in statistical methods and tools for data analysis and validation.

• Experience with statistical process control (SPC) and data analysis tools (e.g., Minitab, JMP).
• Familiarity with lean manufacturing principles and Six Sigma methodologies.
• Project management certification (e.g., PMP, CAPM).
• Proficiency in programming languages for data analysis or test automation (e.g., Python, R, MATLAB).
• Advanced degree in a relevant engineering or scientific discipline.

Validation Engineer, QA Validation Engineer, Senior Validation Engineer, Principal Validation Engineer, CSV Engineer, Computer System Validation Engineer, Process Validation Engineer, Equipment Validation Engineer, Cleaning Validation Engineer, Test Engineer, Quality Engineer, Validation Specialist, Validation Lead, Validation Manager

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.