Engineer II, Validation - MTC South - Norwood - USA - MA
5 days ago
Job summary
In this role you will perform duties according to Modernas Commissioning Qualification and Validation program execute assigned qualification activities own delivery of capital projects site requalification periodic review programs ensuring systems equipment remain in operational state of compliance.
Responsibilities
- Perform commissioning qualification validation activities for Modenas GMP manufacturing facility which includes raw material Drug Substance Formulation Drug Product Finished Goods personalized medicine capabilities.
- Working with external validation service providers Responsibilities ensure commitment to key stakeholders are met.
- Ensure validated status of site facilities utilities equipment processes established maintained in accordance internal procedures regulatory requirements industry guidance standards.
- Support new equipment qualification activities for capital operational projects..
- Assist investigation reviews deviation investigations related manufacturing process equipment utilities automation computer systems validation laboratory instruments..
Job description
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