Manufacturing Validation Engineer - Quality & Compliance

The Pivot Group Careers; Spring Lake (MI); On-site; USD 79,000 - 119,000; Full time

Job summary

The Pivot Group Careers is actively building a network of Validation Engineers to support manufacturers in and around Spring Lake, MI. This role focuses on ensuring robust validation of equipment and processes in a manufacturing setting.

Applicants should have a strong background in statistics, GMP/ISO/FDA guidelines, and documentation. This network offers long-term fit and opportunities across multiple local manufacturers, with salary ranges aligned to experience.

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

• 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.
• 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.

Skills

Minitab

Technical Writing

Data Analysis

Lean Manufacturing

Six Sigma

Regulatory Requirements

Validation

Quality Assurance

Education

Bachelor's degree in engineering or related technical field

Tools

Validation Protocols

Job description

The Pivot Group Careers is actively building a network of Validation Engineers to support manufacturers in and around Spring Lake, MI. This role focuses on ensuring robust validation of equipment and processes in a manufacturing setting.

Applicants should have a strong background in statistics, GMP/ISO/FDA guidelines, and documentation. This network offers long-term fit and opportunities across multiple local manufacturers, with salary ranges aligned to experience.