Validation Engineer - Wayland Area

We are collaborating with multiple companies in Wayland seeking experienced Validation Engineers. These organizations value long-term fit and are looking for professionals who bring both skill and alignment. By joining our network, you gain access to opportunities tailored to your goals.

• →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 data and author comprehensive validation reports, including deviations and corrective actions.
• →Collaborate with cross-functional teams (e.g., R&D, Quality, Manufacturing) to define validation strategies.
• →Maintain validation master plans and ensure all validation activities are documented and archived properly.
• →Investigate and troubleshoot validation failures, implementing effective solutions and preventative measures.
• →Stay current with industry standards and regulatory guidelines related to validation practices.

• 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).
• Strong understanding of GxP, FDA regulations (e.g., 21 CFR Part 820, Part 211), and ISO standards (e.g., ISO 13485).
• Proven experience with validation lifecycle activities including IQ, OQ, PQ for equipment, processes, and software.
• Excellent technical writing skills for creating and executing validation protocols and reports.

• Experience with Computer System Validation (CSV) in an FDA-regulated environment.
• Familiarity with data integrity principles and ALCOA+.
• Knowledge of GAMP 5 guidelines.
• Experience with risk-based validation methodologies.
• Scripting or programming experience (e.g., Python, SQL) 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.