Validation Engineer - St. Johns Area

We partner with manufacturers across St. Johns 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 (IQ, OQ, PQ) for equipment, processes, and software.
• →Perform risk assessments and generate validation plans.
• →Analyze validation data, write reports, and present findings.
• →Investigate deviations and non-conformances during validation activities.
• →Ensure compliance with regulatory requirements (e.g., FDA, GMP) and internal quality standards.
• →Collaborate with cross-functional teams including R&D, manufacturing, and quality assurance.
• →Maintain validation documentation throughout the equipment and process lifecycle.

• 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 validation lifecycle activities, including IQ, OQ, PQ protocols and reports.
• Proficiency in statistical analysis and data interpretation for validation purposes.

• 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 approaches.
• Scripting or programming experience (e.g., Python, SQL) for data analysis or test automation.

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 Consultant, 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.