Validation Engineer | IQ/OQ/PQ & CSV Expert

the-pivot-group-careers

Hyattsville (MD, MI)

On-site

USD 81,000 - 121,000

Full time

3 days ago

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Job summary

The Pivot Group Network in Hart, MI is seeking a Validation Engineer with experience validating manufacturing equipment, processes, and systems in regulated environments. You will lead IQ, OQ and PQ activities, assess risks, analyze data, write validation reports and present findings to cross-functional teams to ensure compliance with FDA/ISO standards.

Collaboration with engineering, quality and production is essential to drive successful project execution and ongoing lifecycle management of

Qualifications

Bachelor's degree in engineering, life sciences or related field.
3+ years of validation in a regulated manufacturing environment.
Experience authoring, executing and reviewing validation protocols and reports.

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 reports and present findings to cross-functional teams.
Investigate and resolve deviations or non-conformances in validation activities.
Support lifecycle management of validated systems including revalidation and change control.
Collaborate with engineering, quality and production to drive project execution.