Validation Engineer - Muskegon Area

We are collaborating with manufacturing firms in Muskegon that are seeking skilled Validation Engineers. These organizations are dedicated to maintaining high standards and are looking for professionals who can contribute effectively. By joining our network, you position yourself for opportunities aligned with your career goals.

• →Develop and execute validation protocols for equipment, processes, and software.
• →Perform IQ, OQ, and PQ activities for new and modified manufacturing systems.
• →Conduct risk assessments and develop mitigation strategies for validation activities.
• →Analyze validation data, generate reports, and present findings to stakeholders.
• →Ensure compliance with regulatory requirements (e.g., FDA, ISO) and internal quality standards.
• →Investigate and resolve deviations and non-conformances related to validated systems.
• →Maintain validation master plans and associated documentation throughout the lifecycle.
• →Collaborate with cross-functional teams (e.g., R&D, Quality, Manufacturing) on validation efforts.

• 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).
• Proven experience authoring and executing validation protocols and reports (IQ, OQ, PQ) for equipment, processes, and software.
• Strong understanding of cGMP, FDA regulations (e.g., 21 CFR Part 820, Part 210/211, Part 11), and industry standards (e.g., ISO 13485).
• Experience with statistical methods for validation and process control.

• Experience with statistical process control (SPC) and data analysis tools (e.g., Minitab, JMP).
• Familiarity with automation systems and software used in manufacturing (e.g., SCADA, DCS, PLCs).
• Project management certification (e.g., PMP, CAPM) or demonstrated experience leading validation projects.
• Advanced degree in a relevant scientific or engineering discipline.
• Lean Six Sigma Green or Black Belt 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.