Senior Validation Engineer | FDA/GxP Focus & Growth

the-pivot-group-careers; Montague Township (MI); On-site; USD 78,000 - 118,000; Full time

Job summary

The Pivot Group Network is expanding its West Michigan manufacturing-focused recruiting network with a Validation Engineer opportunity in Montague, MI. The role centers on developing and executing validation protocols for equipment, processes, and systems, ensuring IQ/OQ/PQ activities are completed to meet regulatory expectations.

Ideal candidates hold a Bachelor's degree in engineering or a related field and 3+ years of validated manufacturing experience, with strong knowledge of GxP, FDA

Qualifications

• Bachelor's degree in engineering or a related scientific discipline.
• 3+ years in validation activities within a regulated manufacturing environment.
• Strong understanding of GxP, FDA regulations, and industry standards.
• Experience with validation lifecycle activities, IQ/OQ/PQ protocols and reports.

Responsibilities

• Develop and execute validation protocols for equipment, processes, and systems.
• Perform IQ, OQ, and PQ activities for new and modified manufacturing equipment.
• Conduct risk assessments and develop validation strategies based on regulatory requirements.
• Analyze validation data, write reports, and present findings to cross-functional teams.
• Investigate and resolve deviations and non-conformances during validation activities.
• Maintain validation documentation in accordance with internal procedures and external regulations.
• Support change control activities by assessing validation impact and developing revalidation plans.

Education

Bachelor's degree in engineering or related field

Tools

GxP standards

FDA regulations

ISO 13485

21 CFR Part 820

21 CFR Part 11

Job description

The Pivot Group Network is expanding its West Michigan manufacturing-focused recruiting network with a Validation Engineer opportunity in Montague, MI. The role centers on developing and executing validation protocols for equipment, processes, and systems, ensuring IQ/OQ/PQ activities are completed to meet regulatory expectations.

Ideal candidates hold a Bachelor's degree in engineering or a related field and 3+ years of validated manufacturing experience, with strong knowledge of GxP, FDA