Senior Validation Engineer: IQ/OQ/PQ & Compliance

the-pivot-group-careers; Grandville (MI); On-site; USD 75,000 - 114,000; Full time

Job summary

The Pivot Group Network in Grandville, MI is seeking a Validation Engineer to develop and execute IQ/OQ/PQ protocols for manufacturing equipment, processes, and systems.

You will analyze data, write reports, support audits, and collaborate with R&D, Quality, and Manufacturing to ensure regulatory compliance and successful product launches.

A Bachelor's degree in engineering and 3+ years of validation experience in regulated environments are preferred.

Qualifications

• Bachelor's degree in engineering or related discipline.
• 3+ years of validation experience in regulated manufacturing.
• Knowledge of GxP regulations such as FDA 21 CFR Part 820, Part 210/211, ISO 13485.

Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and systems.
• Perform risk assessments and generate validation plans to ensure regulatory compliance.
• Analyze validation data, write detailed reports, and present findings to cross-functional teams.
• Investigate deviations and non-conformances during validation activities.
• Collaborate with R&D, Quality, and Manufacturing for tech transfer and launches.
• Maintain validation documentation and records.
• Support internal and external audits with validation expertise.

Skills

Validation expertise

Regulatory knowledge

Data analysis

Education

Bachelor's degree in engineering or related field

Tools

IQ/OQ/PQ methodology

Statistical methods

Job description

The Pivot Group Network in Grandville, MI is seeking a Validation Engineer to develop and execute IQ/OQ/PQ protocols for manufacturing equipment, processes, and systems.

You will analyze data, write reports, support audits, and collaborate with R&D, Quality, and Manufacturing to ensure regulatory compliance and successful product launches.

A Bachelor's degree in engineering and 3+ years of validation experience in regulated environments are preferred.