Validation Engineer | IQ/OQ/PQ Expert in GMP Compliance

the-pivot-group-careers; East Lansing (MI); On-site; USD 79,000 - 119,000; Full time

Job summary

The Pivot Group Network in East Lansing, MI seeks a Validation Engineer to join a network of manufacturing-focused opportunities. You will develop and execute validation protocols for equipment, processes, and software, and perform IQ/OQ/PQ activities.

You will analyze data, author reports, address deviations, ensure cGMP and FDA compliance, and collaborate with R&D, Manufacturing and Quality to define validation strategies in a dynamic, long-term-fit role.

Qualifications

• Experience developing and executing validation protocols.
• Familiarity with IQ/OQ/PQ exercises.
• Understanding of cGMP, FDA regulations and quality standards.

Responsibilities

• Develop and execute validation protocols for equipment, processes, and software.
• Perform IQ, OQ, and PQ activities for new and modified systems.
• Analyze validation data and author comprehensive validation reports.
• Investigate and resolve deviations and non-conformances during validation activities.
• Ensure all validation activities comply with cGMP, FDA, and internal quality standards.
• Collaborate with cross-functional teams to define validation strategies.
• Maintain and update validation documentation throughout the system lifecycle.

Skills

Strong communication

Tools

Minitab

JMP

PLCs

SCADA

MES

Job description

The Pivot Group Network in East Lansing, MI seeks a Validation Engineer to join a network of manufacturing-focused opportunities. You will develop and execute validation protocols for equipment, processes, and software, and perform IQ/OQ/PQ activities.

You will analyze data, author reports, address deviations, ensure cGMP and FDA compliance, and collaborate with R&D, Manufacturing and Quality to define validation strategies in a dynamic, long-term-fit role.