Validation Engineer - Newaygo Area

We collaborate with manufacturing companies in the Newaygo region seeking Validation Engineers. These employers partner with us because they want real insight into candidates—not just resumes. By joining our network, you gain access to roles worth considering.

• →Develop and execute 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, write comprehensive validation reports, and present findings to stakeholders.
• →Investigate and resolve deviations or non-conformances identified during validation activities.
• →Collaborate with cross-functional teams, including R&D, Quality, and Manufacturing, to define validation strategies.
• →Maintain validation documentation in accordance with internal procedures and external regulations.
• →Support continuous improvement initiatives by optimizing validation processes and methodologies.

• 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).
• Proven experience with validation lifecycle activities, including IQ, OQ, PQ protocols and reports.
• Proficiency in statistical analysis tools for process validation and data analysis.

• Experience with statistical process control (SPC) and data analysis tools (e.g., Minitab, JMP).
• Familiarity with automation systems and software (e.g., SCADA, DCS, PLC programming).
• Certification in Lean Six Sigma (Green Belt or Black Belt).
• Project management experience or certification (e.g., PMP).
• Experience with Computerized Maintenance Management Systems (CMMS) or Enterprise Asset Management (EAM) software.

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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.