Validation Engineer - Byron Center Area

We are collaborating with multiple companies in Byron Center 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 for equipment, processes, and software.
• →Perform risk assessments and generate validation plans to ensure compliance with regulatory requirements.
• →Analyze validation data, write reports, and present findings to cross-functional teams.
• →Investigate and resolve validation deviations and non-conformances.
• →Maintain validation master plans and schedules, ensuring timely completion of validation activities.
• →Collaborate with engineering, quality, and production teams to integrate validation into the product lifecycle.

• 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).
• Demonstrated knowledge of GxP, FDA regulations (e.g., 21 CFR Part 11, Part 820), and industry standards (e.g., ISO 13485).
• Proven experience in developing and executing validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Strong technical writing skills for creating clear and concise validation documentation.

• Experience with statistical process control (SPC) and data analysis tools (e.g., Minitab, JMP).
• Familiarity with automation systems and software (e.g., PLC, SCADA, MES).
• ASQ certifications (e.g., CQE, CSSBB, CQA).
• Knowledge of cybersecurity principles in manufacturing environments.
• Experience with risk management methodologies beyond FMEA (e.g., HAZOP, PHA).

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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.