Validation Engineer – Regulated Manufacturing

the-pivot-group-careers; Cadillac (MI); On-site; USD 75,000 - 114,000; Full time

Job summary

The Pivot Group Network is recruiting a Validation Engineer for Cadillac, MI. This role focuses on developing and executing IQ/OQ/PQ validation protocols for equipment, processes and software within a regulated manufacturing setting.

Ideal candidates bring 3+ years of validation experience, strong knowledge of GxP regulations, and proven skills in technical writing and data analysis. The position emphasizes quality and compliance in a manufacturing environment in West Michigan.

Qualifications

• Bachelor's degree in engineering or related field.
• 3+ years of validation experience in regulated manufacturing.
• Strong understanding of GxP regulations (FDA 21 CFR Part 820, Part 210/211, ISO 13485).
• Experience with IQ, OQ, PQ for equipment, processes and software.
• Excellent technical writing for validation protocols and reports.

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.
• Ensure compliance with regulatory requirements (FDA, GMP) and internal standards.
• Investigate deviations and implement CAPAs related to validation activities.
• Support change control by assessing validation impact and revalidation.

Skills

IQ/OQ/PQ validation

Risk assessment

Data analysis

Regulatory compliance

Technical writing

Education

Bachelor's degree in engineering

Tools

Minitab

JMP

PLC

SCADA

Job description

The Pivot Group Network is recruiting a Validation Engineer for Cadillac, MI. This role focuses on developing and executing IQ/OQ/PQ validation protocols for equipment, processes and software within a regulated manufacturing setting.

Ideal candidates bring 3+ years of validation experience, strong knowledge of GxP regulations, and proven skills in technical writing and data analysis. The position emphasizes quality and compliance in a manufacturing environment in West Michigan.