Validation Engineer: Manufacturing Quality & Compliance

The Pivot Group Careers; Kentwood (MI); On-site; USD 78,000 - 118,000; Full time

Job summary

The Pivot Group Network in Kentwood, MI is seeking a Validation Engineer to lead and execute validation activities across equipment, processes, and software systems. This role involves coordinating validation schedules with production, engineering, and quality teams, and maintaining rigorous documentation to meet GMP, ISO, and FDA expectations.

Ideal candidates hold a Bachelor's in engineering with experience writing validation protocols in manufacturing settings, plus familiarity with

Qualifications

• 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

• 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.
• 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.

Skills

Minitab

Statistical analysis

GMP ISO FDA

Technical writing

Validation protocols

Quality standards

Manufacturing QC

Education

Bachelor's degree in engineering

Tools

Python

R

Data acquisition systems

Validation software

Job description

The Pivot Group Network in Kentwood, MI is seeking a Validation Engineer to lead and execute validation activities across equipment, processes, and software systems. This role involves coordinating validation schedules with production, engineering, and quality teams, and maintaining rigorous documentation to meet GMP, ISO, and FDA expectations.

Ideal candidates hold a Bachelor's in engineering with experience writing validation protocols in manufacturing settings, plus familiarity with