Position Details
About this role
This role provides quality oversight of qualification and validation activities at the Devens MA Cell Therapy Facility, ensuring compliance and supporting validation lifecycle management.
Key Responsibilities
- Review qualification documentation
- Manage validation lifecycle
- Support CQV and CSV activities
- Perform risk assessments
- Ensure data integrity
Technical Overview
The position involves managing qualification, validation, CQV, CSV, and change control activities in a healthcare manufacturing setting, with a focus on process validation and data integrity.
Ideal Candidate
The ideal candidate is a mid-level quality engineer with experience in qualification, validation, and process validation activities within a healthcare manufacturing environment. They should be detail-oriented and capable of managing validation lifecycle activities.
Must-Have Skills
Nice-to-Have Skills
Tools & Platforms
Required Skills
Hard Skills
Soft Skills
Industry & Role
Keywords for Your Resume
Deal Breakers
Lack of validation experience, No familiarity with CQV or CSV, Unwilling to work in a hybrid environment, No experience with qualification activities
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