Senior Validation Engineer - GMP/Regulated Manufacturing

the-pivot-group-careers; Ludington (MI); On-site; USD 74,000 - 113,000; Full time

Job summary

The Pivot Group Network in Ludington, MI is seeking a Validation Engineer to lead validation initiatives for manufacturing equipment, processes, and software. You will develop and execute IQ, OQ, and PQ protocols, perform risk assessments, and ensure compliance with regulatory requirements.

You will collaborate with engineering, quality, and production teams, maintain validation master plans, and manage change control.

Qualifications

• Bachelor's degree in engineering or related field.
• 3+ years in validation within regulated manufacturing.
• Strong knowledge of GxP and FDA/ISO standards.
• Experience developing and executing IQ/OQ/PQ protocols.

Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Perform risk assessments and generate validation plans to ensure regulatory compliance.
• Analyze data, write validation reports, and present findings to cross-functional teams.
• Investigate deviations, implement corrective actions, and manage change control processes.
• Maintain validation master plans, schedules, and documentation in an organized manner.
• Collaborate with engineering, quality, and production teams to ensure validation activities.

Skills

Validation data analysis

Risk assessment

Cross-functional collaboration

IQ/OQ/PQ execution

Regulatory compliance

Education

Bachelor's degree in engineering

Job description

The Pivot Group Network in Ludington, MI is seeking a Validation Engineer to lead validation initiatives for manufacturing equipment, processes, and software. You will develop and execute IQ, OQ, and PQ protocols, perform risk assessments, and ensure compliance with regulatory requirements.

You will collaborate with engineering, quality, and production teams, maintain validation master plans, and manage change control.