Validation Engineer - Otsego Area

We are working with companies in Otsego 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 validation data, write reports, and ensure compliance with regulatory requirements (e.g., FDA, ISO).
• →Investigate deviations and out-of-specification results during validation activities, implementing corrective actions.
• →Collaborate with cross-functional teams (e.g., R&D, Quality, Manufacturing) to integrate validation into project lifecycles.
• →Maintain and update validation documentation, including procedures, master plans, and executed protocols.
• →Support internal and external audits by providing validation expertise and documentation.

• Bachelor's degree in engineering or a related scientific discipline.
• 3+ years of experience in validation within a regulated manufacturing environment (e.g., medical devices, pharmaceuticals).
• Strong understanding of GxP regulations (e.g., 21 CFR Part 820, Part 210/211, Part 11).
• Proven experience in developing and executing validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Excellent technical writing and communication skills for authoring validation documentation.

• Experience with Computer System Validation (CSV) in an FDA-regulated environment.
• Familiarity with GAMP 5 guidelines.
• Knowledge of statistical methods for data analysis and sampling.
• Experience with risk-based validation approaches.
• Scripting or programming experience (e.g., Python, R) for data analysis or automation.

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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.