Change Control & Validation Specialist
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:
- Bachelors 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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