Validation Engineer - Kentwood Area

We are collaborating with manufacturing firms in Kentwood 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 (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 validation reports, and present findings to cross-functional teams.
• →Investigate and resolve deviations, non-conformances, and out-of-specification results during validation activities.
• →Support the lifecycle management of validated systems, including revalidation, periodic reviews, and change control.
• →Collaborate with engineering, quality assurance, and production teams to ensure successful project implementation and ongoing compliance.
• →Maintain and update validation documentation, ensuring accuracy, completeness, and adherence to established 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, biotech).
• Strong understanding of GxP regulations (e.g., 21 CFR Part 820, Part 210/211, ISO 13485) and industry guidance (e.g., GAMP 5, ICH Q7, Q9, Q10).
• Proven experience in developing, executing, and summarizing validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Proficiency in statistical methods and data analysis for validation activities.

• Experience with statistical process control (SPC) and data analysis tools (e.g., Minitab, JMP).
• Familiarity with automation systems and software (e.g., PLCs, SCADA, MES).
• Certification in Lean Six Sigma (Green Belt or Black Belt).
• Project management experience or certification (e.g., PMP).
• Proficiency in programming languages relevant to automation or data analysis (e.g., Python, R).

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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.