Validation Engineer - Charlotte Area
Job Description:
Validation Engineer | Charlotte, MI
Salary Range: $81,000 - $121,000 depending on experience
Are you ready to take on a challenging and rewarding opportunity in {{role_field}}? The Pivot Group is committed to building meaningful connections in manufacturing. We partner with leading companies in Charlotte seeking Validation Engineers.
The Opportunity
We partner with manufacturers across Charlotte 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.
Key Responsibilities
- Develop and execute validation protocols for new equipment, processes, and software.
- Document all validation activities, including deviations, changes, and final reports.
- Identify and assess potential risks to product quality and process integrity.
- Perform IQ, OQ, and PQ (Installation Qualification, Operational Qualification, Performance Qualification) for manufacturing equipment.
- Review and approve validation documentation generated by other departments.
- Maintain validation status of equipment and processes through periodic revalidation.
- Troubleshoot and resolve validation-related issues and deviations.
- Ensure compliance with relevant regulatory requirements (e.g., FDA, GMP, ISO).
Recommended Qualifications
- Bachelor's degree in Engineering (e.g., Electrical, Mechanical, Chemical, Biomedical) or a related scientific field.
- Proven experience in validation activities within a regulated manufacturing environment (e.g., GMP, ISO 13485).
- Strong understanding of validation principles, including IQ, OQ, PQ, and CSV.
- Familiarity with relevant regulatory guidelines (e.g., FDA, EMA).
- Experience with protocol development, execution, and report generation.
- Ability to troubleshoot and resolve validation-related issues.
Bonus Qualifications
- - Experience with statistical process control (SPC) software and analysis.
- - Familiarity with Lean Manufacturing principles and their application in validation.
- - Knowledge of Good Automated Manufacturing Practice (GAMP) guidelines.
- - Experience with root cause analysis (RCA) methodologies for deviation investigations.
Job Titles That Should Apply
Validation Specialist, Qualification Engineer, V&V Engineer, Process Validation Engineer, Quality Engineer, CSV Engineer, Computer System Validation Engineer, C&Q Engineer, Equipment Validation Engineer, Test and Validation Engineer, Software Validation Engineer, Commissioning and Qualification Engineer, Automation Validation Engineer, Manufacturing Validation Engineer, CQV Engineer
Why Pivot Group
The Pivot Group 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.
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. The Pivot Group 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.
Required Skills:
GMP Resume Protocol Offers Support Lean Manufacturing Product Quality Development Root Cause Analysis ROOT Regulatory Requirements Analysis Compliance Salary Hiring Partnerships Compensation Validation Commissioning Manufacturing Automation C Preparation Software Documentation Engineering
Salary Package:
$ 81,000.00 - 121,000.00 (US Dollar)