Validation Engineer - Charlotte Area

We are collaborating with multiple companies in Charlotte 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.
• →Analyze validation data, write reports, and present findings to stakeholders.
• →Investigate and resolve deviations and non-conformances during validation activities.
• →Ensure compliance with cGMP, FDA regulations, and internal quality standards.
• →Collaborate with cross-functional teams (e.g., R&D, Quality, Manufacturing) to support new product introductions and process improvements.
• →Maintain and update validation documentation throughout the equipment and process lifecycle.

• 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).
• Demonstrated expertise in authoring, executing, and reviewing validation protocols and reports (IQ, OQ, PQ) for equipment, processes, and software.
• Strong understanding of cGMP, FDA regulations (e.g., 21 CFR Part 11, Part 820), and industry standards (e.g., ISO 13485).
• Experience with risk-based validation approaches and statistical methods for data analysis.

• Experience with statistical process control (SPC) and data analysis tools (e.g., Minitab, JMP).
• Familiarity with automation systems and software validation in a manufacturing context (e.g., MES, SCADA, PLCs).
• Certification in quality assurance (e.g., ASQ Certified Quality Engineer, CQE) or Six Sigma (Green Belt, Black Belt).
• Demonstrated ability to lead or mentor junior validation engineers.
• Proficiency in programming or scripting languages relevant to data analysis or test automation (e.g., Python, R).

Validation Engineer, Senior Validation Engineer, Principal Validation Engineer, CSV Engineer, Computer System Validation Engineer, Process Validation Engineer, Equipment Validation Engineer, Software Validation Engineer, Validation Specialist, Validation Lead, Validation Manager, Quality Engineer (Validation), QA Validation Engineer

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.