Validation Engineer — Quality & Compliance Champion

the-pivot-group-careers

Wayland Township (MI)

On-site

USD 77,000 - 117,000

Full time

3 days ago

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Job summary

The Pivot Group Network in Wayland, MI is seeking an experienced Validation Engineer to develop and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and software. The role emphasizes risk assessments, data analysis, and reporting within a regulated manufacturing setting.

Qualifications include a bachelor’s degree in engineering, 3+ years in validation, and familiarity with FDA GxP and ISO standards.

Qualifications

Bachelor's degree in engineering or related scientific discipline.
3+ years of validation experience in a regulated manufacturing environment (medical device/pharma).
Strong understanding of GxP, FDA regulations and ISO standards.
Experience with validation lifecycle activities (IQ/OQ/PQ) for equipment, processes, and software.
Excellent technical writing skills for protocols and reports.

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 and author validation reports, including deviations and corrective actions.
Collaborate with cross-functional teams to define validation strategies.
Maintain validation master plans and ensure documentation and archiving.
Investigate and troubleshoot validation failures and implement corrective actions.
Stay current with industry standards and regulatory guidelines.