Validation Engineer - Charlotte Area

the-pivot-group-careers; Charlotte (MI); On-site; USD 81,000 - 121,000; Full time

Job summary

The Pivot Group Network, a West Michigan manufacturing-focused recruiting group, partners with Charlotte-based manufacturers to identify a qualified Validation Engineer. You will develop and execute IQ/OQ/PQ validation protocols for equipment, processes, and software while ensuring cGMP and FDA compliance.

You will collaborate with R&D, Quality and Manufacturing teams, prepare reports, analyze data, address deviations, and maintain validation documentation throughout the lifecycle.

Qualifications

• Bachelor's degree required in engineering or life sciences.
• 3+ years in validation in regulated manufacturing.
• Experience authoring/executing validation protocols and reports (IQ/OQ/PQ).
• Strong cGMP and FDA regulation knowledge.
• Experience with risk-based validation and statistics.

Responsibilities

• Develop and execute IQ, OQ, PQ validation protocols for equipment, processes, and software.
• Perform risk assessments and generate validation plans.
• Analyze validation data, write reports, present findings to stakeholders.
• Investigate deviations and non-conformances during validation activities.
• Ensure compliance with cGMP, FDA regulations and internal standards.
• Collaborate with cross-functional teams to support new products and improvements.
• Maintain and update validation documentation throughout lifecycle.

Skills

Validation protocols & reports

cGMP/FDA knowledge

Risk-based validation

Data analysis & statistics

Mentoring/leadership

Education

Bachelor's degree in Engineering, Life Sciences or related field

Tools

Minitab/JMP

MES/SCADA/PLCs

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.