Validation Engineer - Holt Area

We partner with manufacturers across Holt seeking Validation Engineers who want more than a lateral move. These companies hire intentionally, and we connect them with professionals ready for roles that fit.

• →Develop and execute validation protocols for equipment, processes, and software.
• →Perform IQ, OQ, and PQ activities for new and modified systems.
• →Analyze validation data and author comprehensive validation reports.
• →Investigate and resolve deviations and non-conformances during validation activities.
• →Ensure all validation activities comply with cGMP, FDA, and internal quality standards.
• →Maintain and update validation documentation throughout the system lifecycle.
• →Collaborate with cross-functional teams, including R&D, Quality, and Manufacturing.

• Bachelor's degree in Engineering, Life Sciences, or a related technical field.
• 2+ years experience in validation activities within a regulated manufacturing environment (e.g., medical device, pharmaceutical, biotech).
• Strong understanding of GxP regulations (e.g., FDA 21 CFR Part 820, Part 210/211, ISO 13485).
• Experience with various validation methodologies including IQ, OQ, PQ, process validation, and software validation.
• Proficiency in writing and executing validation protocols and reports.

• Experience with statistical process control (SPC) and data analysis tools (e.g., MiniTab, JMP).
• Familiarity with automation systems and software validation (e.g., SCADA, DCS, PLCs).
• Certified Quality Engineer (CQE) or similar professional certification.
• Knowledge of cybersecurity principles as they apply to manufacturing systems.

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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.