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 Network, a West Michigan manufacturing-focused recruiting group, is committed to building meaningful connections in manufacturing. We partner with leading companies in Charlotte seeking Validation Engineers.

We are building our network of talent in this field across West Michigan and the broader manufacturing region Pivot Group Network serves. Our partner companies may or may not have an immediate opening for this exact role today, but we actively look for skilled professionals in the regions where they operate. If there is alignment now or in the near future, we reach out.

The Opportunity

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.

Key Responsibilities

• 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.

Recommended Qualifications

• 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.

Bonus Qualifications

• 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).

Job Titles That Should Apply

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

Why The Pivot Group Network

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 ;br>
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 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.

Required Skills:
Minitab
Resume
Data
Offers
Life Sciences
Test Automation
Access
Support
Six Sigma
Assurance
Analysis
Compliance
Salary
Hiring
Partnerships
Recruiting
Compensation
Validation
R
Manufacturing
Quality Assurance
Automation
Programming
Regulations
Preparation
Data Analysis
Software
Documentation
Engineering
Python

Salary Package:
$ 81,000.00 - 121,000.00 (US Dollar)