Manufacturing Validation Engineer (Ludington)

The Pivot Group Careers; Ludington (MI); On-site; USD 77,000 - 117,000; Full time

Job summary

The Pivot Group Network is actively sourcing Validation Engineers for opportunities in the Ludington, MI region. These roles involve designing, executing, and documenting validation activities across equipment, processes, and software to meet regulatory standards.

Selected candidates will collaborate with manufacturing teams, ensure robust qualification work, and maintain compliant validation records while supporting change control and continuous improvement initiatives.

Qualifications

• Strong technical writing and documentation skills.
• Ability to read schematics, specifications, and process diagrams.
• 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 GMP, ISO 9001, or FDA requirements.

Responsibilities

• Review and update SOPs tied to validated processes.
• Write and execute validation protocols for equipment, processes, and software.
• 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

Technical writing

Reading schematics

Statistical analysis

Validation protocols

GMP/ISO/FDA awareness

Manufacturing exposure

Data interpretation

Education

Bachelor’s degree in engineering or related field

Job description

The Pivot Group Network is actively sourcing Validation Engineers for opportunities in the Ludington, MI region. These roles involve designing, executing, and documenting validation activities across equipment, processes, and software to meet regulatory standards.

Selected candidates will collaborate with manufacturing teams, ensure robust qualification work, and maintain compliant validation records while supporting change control and continuous improvement initiatives.