Senior Validation Engineer

Full-time Engineers

Job Description:
This position is responsible for planning, executing, and documenting commissioning, qualification, and validation (CQV) activities to ensure all systems meet stringent regulatory and client-specific requirements.

The Senior Validation Engineer will act as a subject matter expert, collaborating closely with cross-functional teams, including Manufacturing, Facilities, Quality Control and Quality Assurance to deliver robust validation strategies that enable compliant and efficient operations in an early-phase clinical environment.



Roles & Responsibilities:

• Independently understanding quality standards, cGMP's, and regulatory standards to support team in compliance of validation effort.

• Authoring, editing, and executing technical commissioning, qualification and validation documentation for facilities, utilities, and standard equipment/systems/software.

• Actively consult clients on regulatory val...