Validation Engineer — Manufacturing & Compliance

the-pivot-group-careers; Wyoming (MI); On-site; USD 76,000 - 116,000; Full time

Job summary

The Pivot Group Network in Wyoming, MI, is seeking a Validation Engineer to lead IQ/OQ/PQ activities for equipment, processes and software. You will perform risk assessments, generate validation plans, analyze data, and write reports to support regulatory compliance (FDA, ISO) and internal quality standards.

Collaborating with R&D, manufacturing, quality and regulatory affairs, you will ensure audit readiness and drive CAPAs and change controls.

Qualifications

• Experience validating equipment, processes, and software across IQ/OQ/PQ.
• Ability to perform risk assessments and generate validation plans.
• Knowledge of FDA/ISO regulatory requirements and internal quality standards.

Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Perform risk assessments and generate validation plans.
• Analyze validation data, write reports, and present findings.
• Ensure compliance with regulatory requirements (e.g., FDA, ISO) and internal quality standards.
• Investigate deviations and implement corrective and preventive actions (CAPAs) related to validation activities.
• Support change control activities by assessing validation impact.
• Maintain validation documentation and ensure audit readiness.
• Collaborate with cross-functional teams including R&D, manufacturing, quality, and regulatory affairs.

Skills

Communication skills

Job description

The Pivot Group Network in Wyoming, MI, is seeking a Validation Engineer to lead IQ/OQ/PQ activities for equipment, processes and software. You will perform risk assessments, generate validation plans, analyze data, and write reports to support regulatory compliance (FDA, ISO) and internal quality standards.

Collaborating with R&D, manufacturing, quality and regulatory affairs, you will ensure audit readiness and drive CAPAs and change controls.