Senior Validation Engineer - IQ/OQ/PQ & Compliance

the-pivot-group-careers; Georgetown Charter Township (MI); On-site; USD 80,000 - 120,000; Full time

Job summary

The Pivot Group Network in Michigan is seeking a Validation Engineer in Jenison to lead IQ, OQ, and PQ programs for equipment, processes, and software. You will drive validation activities and work with cross-functional teams to deliver compliant results.

The role emphasizes data analysis, report writing, deviation investigations, and adherence to cGMP and FDA requirements while supporting continuous improvement in a manufacturing context.

Qualifications

• Strong communication and problem-solving skills

Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Perform risk assessments and generate validation plans.
• Analyze validation data and write comprehensive validation reports.
• Investigate deviations and non-conformances during validation activities.
• Ensure compliance with cGMP, FDA regulations, and internal quality standards.
• Collaborate with cross-functional teams including R&D, Quality, and Manufacturing.
• Maintain and update validation documentation throughout the lifecycle of equipment and processes.

Skills

Communication

Problem-solving

Job description

The Pivot Group Network in Michigan is seeking a Validation Engineer in Jenison to lead IQ, OQ, and PQ programs for equipment, processes, and software. You will drive validation activities and work with cross-functional teams to deliver compliant results.

The role emphasizes data analysis, report writing, deviation investigations, and adherence to cGMP and FDA requirements while supporting continuous improvement in a manufacturing context.