Validation Engineer - Lead IQ/OQ/PQ in Manufacturing

the-pivot-group-careers; Michigan; On-site; USD 72,000 - 111,000; Full time

Job summary

The Pivot Group Network in Allegan, MI is seeking a Validation Engineer to lead validation activities for equipment, processes, and software. The role emphasizes adherence to regulatory standards and high-quality documentation.

Ideal candidates will have 3+ years in validation within regulated manufacturing, familiarity with FDA/GxP, and experience in IQ/OQ/PQ protocols, data analysis, and report generation.

Qualifications

• Bachelor's degree in engineering or a related scientific discipline is required.
• 3+ years of validation experience in a regulated manufacturing environment.
• Understanding of GxP, FDA regulations, and ISO 13485 is preferred.
• Experience authoring and executing validation protocols for equipment, processes, and software.

Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Perform risk assessments and generate validation plans.
• Analyze data, write validation reports, and present findings.

Skills

GxP knowledge

Regulatory awareness

Statistical analysis

Education

Bachelor's degree in engineering or related field

Tools

MiniTab

R

Python

Job description

The Pivot Group Network in Allegan, MI is seeking a Validation Engineer to lead validation activities for equipment, processes, and software. The role emphasizes adherence to regulatory standards and high-quality documentation.

Ideal candidates will have 3+ years in validation within regulated manufacturing, familiarity with FDA/GxP, and experience in IQ/OQ/PQ protocols, data analysis, and report generation.