Change Control & Validation Specialist, MAGandiva Insights • Boston, MA, United States

Change Control & Validation Specialist, MA

Gandiva Insights • Boston, MA, United States

7 days ago

Job type

Full-time

Quick Apply

Job description

Role : Change Control & Validation Specialist

Location : Boston, MA

Duration : Long-Term

Summary

We are looking for a Change Control & Validation Specialist for a long-term onsite role in Boston, MA. The role supports TrackWise change control, equipment validation, and GMP documentation.

Responsibilities :

Manage TrackWise change control requests
Support IQ / OQ / PQ equipment validation
Work with cross-functional teams to ensure accurate documentation
Review records for GMP and regulatory compliance
Maintain SOPs, protocols, and reports

Requirements :

Bachelor's in Life Sciences, Engineering, or related field

2+ years in pharma / biotech

Strong TrackWise and validation (IQ / OQ / PQ) experience

Knowledge of cGMP and regulatory guidelines

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Validation Specialist • Boston, MA, United States

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