Senior Validation Engineer – IQ/OQ/PQ & Compliance

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

Job summary

The Pivot Group Network seeks an experienced Validation Engineer in Kalamazoo, MI. You will develop and execute validation protocols (IQ/OQ/PQ) for manufacturing equipment, processes and systems, ensuring regulatory compliance and audit readiness.

You will collaborate with engineering, quality and production teams, perform risk assessments, analyze data, and generate comprehensive validation reports to support lifecycle management and change control.

Qualifications

• Bachelor's degree required in Engineering, Life Sciences, or related technical field.
• 3+ years of validation experience in regulated manufacturing environments (medical device, pharma, biotech).
• Strong understanding of GxP, FDA regulations (21 CFR parts), and ISO standards.

Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and systems.
• Perform risk assessments and generate validation plans in compliance with regulatory requirements.
• Analyze validation data, write reports, and present findings to cross-functional teams.
• Investigate deviations or non-conformances identified during validation activities.
• Support lifecycle management of validated systems, including revalidation and change control.
• Collaborate with engineering, quality, and production to ensure project success and compliance.
• Maintain and update validation documentation for audit readiness.

Skills

GxP knowledge

FDA regulations

ISO standards

Statistical methods

Education

Bachelor's degree in Engineering or Life Sciences

Job description

The Pivot Group Network seeks an experienced Validation Engineer in Kalamazoo, MI. You will develop and execute validation protocols (IQ/OQ/PQ) for manufacturing equipment, processes and systems, ensuring regulatory compliance and audit readiness.

You will collaborate with engineering, quality and production teams, perform risk assessments, analyze data, and generate comprehensive validation reports to support lifecycle management and change control.