Genezen
Validation Engineer II/III
Lexington, MA$105k–$130kmidAdded 4 weeks ago
About this role
Genezen is seeking a Validation Engineer II/III to contribute to their rapidly growing gene therapy operations. This role will be crucial in supporting validation and manufacturing activities, ensuring adherence to cGMPs and regulatory requirements through protocol execution, documentation, and risk assessment. You'll collaborate cross-functionally to drive efficiency and quality within a fast-paced, innovative environment.
What you'll do
- Generate and execute validation protocols, analyze data, and create reports.
- Review and approve qualification documentation.
- Support investigations and root cause analysis for deviations.
- Develop and maintain quality system documentation (SOPs, reports).
- Support commissioning and startup activities.
- Identify and implement process improvements.
What they're looking for
- Validation protocols
- cGMP regulations
- Risk assessment
- Data analysis
- Technical documentation
- Process validation
- Clean room experience
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Genezen
Likely interview questions
- Describe your experience with developing validation protocols according to cGMP guidelines.
- Walk me through a time you identified a significant deviation during validation and how you addressed it.