Manufacturing Validation Engineer – Quality & Impact

The Pivot Group Careers; Charlotte (MI); On-site; USD 81,000 - 121,000; Full time

Job summary

The Pivot Group Network is seeking a Validation Engineer to support manufacturers around Charlotte, MI. The role focuses on developing and executing validation protocols for equipment, processes, and software systems in regulated environments.

Candidates should have a bachelor’s degree in engineering or a related field, strong statistical analysis skills, and experience with GMP/ISO or FDA requirements. This opportunity emphasizes collaboration across production, engineering, and quality teams.

Qualifications

• Experience with statistical analysis and test data interpretation.
• Bachelor’s degree in engineering or a related technical field.
• Experience writing and executing validation protocols in a manufacturing setting.
• Familiarity with quality standards such as GMP, ISO 9001, or FDA requirements.
• Strong technical writing and documentation skills.
• Ability to read schematics, specifications, and process diagrams.

Responsibilities

• Review and update standard operating procedures tied to validated processes.
• Write and execute validation protocols for equipment, processes, and software systems.
• Perform installation, operational, and performance qualification activities.
• Collect and analyze test data and document results in validation reports.
• Investigate failures and deviations and support root cause analysis.
• Maintain validation documentation to meet regulatory and quality standards.
• Coordinate validation schedules with production, engineering, and quality teams.
• Support change control by assessing impact and revalidating as needed.

Skills

Statistical analysis

Technical writing

Quality systems

Documentation

Process validation

Education

Bachelor’s degree in engineering or related technical field

Tools

Minitab

Python

Job description

The Pivot Group Network is seeking a Validation Engineer to support manufacturers around Charlotte, MI. The role focuses on developing and executing validation protocols for equipment, processes, and software systems in regulated environments.

Candidates should have a bachelor’s degree in engineering or a related field, strong statistical analysis skills, and experience with GMP/ISO or FDA requirements. This opportunity emphasizes collaboration across production, engineering, and quality teams.