Validation Engineer - IQ/OQ/PQ in Manufacturing

the-pivot-group-careers; Glendale (MI); On-site; USD 72,000 - 111,000; Full time

Job summary

The Pivot Group Network in Michigan is seeking a Validation Engineer to develop and execute validation protocols (IQ, OQ, PQ) for manufacturing equipment, processes, and software. The role involves risk assessment, data analysis, and reporting to cross-functional teams.

Ideal candidates have a Bachelor's degree in engineering, 3+ years of validation experience in regulated manufacturing, and strong knowledge of GxP, FDA/ISO standards, and CSV. Location: Mason, MI with on-site work.

Qualifications

• Bachelor's degree in engineering or related scientific discipline.
• 3+ years of validation experience in regulated manufacturing (medical device/pharma).
• Strong knowledge of GxP regulations (FDA/ISO).
• Experience with IQ/OQ/PQ and CSV validation lifecycle.
• Excellent technical writing for protocols and reports.

Responsibilities

• Develop and execute IQ/OQ/PQ validation protocols for equipment, processes, and software.
• Perform risk assessments and create validation plans per regulatory requirements.
• Analyze data, write reports, and present findings to cross-functional teams.
• Investigate deviations and implement corrective actions during validation.
• Maintain validation documentation and ensure regulatory compliance.
• Collaborate with engineering, quality, and production teams to integrate validation.
• Support change control processes for validated systems.
• Assist in regulatory audits and inspections with documentation.

Skills

Validation experience

GxP compliance

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in engineering

Tools

MiniTab

JMP

SCADA

PLC

FMEA

Job description

The Pivot Group Network in Michigan is seeking a Validation Engineer to develop and execute validation protocols (IQ, OQ, PQ) for manufacturing equipment, processes, and software. The role involves risk assessment, data analysis, and reporting to cross-functional teams.

Ideal candidates have a Bachelor's degree in engineering, 3+ years of validation experience in regulated manufacturing, and strong knowledge of GxP, FDA/ISO standards, and CSV. Location: Mason, MI with on-site work.