Validation Engineer - Manistee Area

We are working with companies in Manistee that are adding Validation Engineers to their teams. These organizations value quality over speed in hiring. By connecting with us, you position yourself for opportunities that align with what you're looking for.

• →Develop and execute validation protocols (IQ, OQ, PQ) for manufacturing equipment and processes.
• →Perform risk assessments and generate validation plans for new and modified systems.
• →Analyze data and author validation reports summarizing testing results and conclusions.
• →Ensure compliance with regulatory requirements (e.g., FDA, ISO) and internal quality standards.
• →Investigate deviations and out-of-specification results during validation activities.
• →Support change control activities by assessing validation impact for proposed changes.
• →Collaborate with cross-functional teams (e.g., R&D, Quality, Manufacturing) on validation efforts.

• Bachelor's degree in engineering or a related scientific discipline.
• 3+ years of experience in validation within a regulated manufacturing environment (e.g., medical device, pharmaceutical).
• Demonstrated knowledge of GxP regulations and industry standards (e.g., FDA 21 CFR Part 820, ISO 13485).
• Experience with various validation activities, including IQ, OQ, PQ for equipment, processes, and software.
• Strong technical writing skills for authoring and reviewing validation protocols and reports.

• Experience with Lean Manufacturing or Six Sigma methodologies.
• Familiarity with data analysis tools (e.g., JMP, Minitab, Python, R).
• Project management certification (e.g., PMP, CAPM).
• Advanced degree in a relevant engineering or scientific field.
• Experience with automation systems (e.g., PLC, SCADA, DCS).

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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.