Job Summary:
The Verification & Validation (V&V) Specialist is responsible for designing, developing, and executing V&V plans, protocols, and reports to ensure that instruments, systems, assays, and software meet defined requirements and intended use. This role works cross-functionally in a regulated R&D environment, supporting product development from concept through transfer and commercialization.
Key Responsibilities:
* Design and execute verification and validation (V&V) protocols for instruments, software, assays, and systems within the R&D laboratory.
* Develop and manage V&V plans and reports in compliance with internal procedures and regulatory requirements.
* Collaborate with cross-functional teams including R&D, Quality Assurance, Regulatory Affairs, and Engineering to define user needs, design inputs, and functional requirements.
* Conduct verification testing to confirm that systems meet design and functional specifications.
* Perform validation testing to ensure products or processes fulfil intended use and performance requirements.
* Lead activities related to technology transfer, scale-up, and process optimization to support timely execution of project milestones.
* Conduct and document risk assessments, such as Failure Modes and Effects Analysis (FMEA), to inform V&V planning and scope.
* Support the implementation and continuous improvement of quality and regulatory compliance processes, including design control, product development lifecycle, and change management.
* Manage and document deviations, CAPAs (Corrective and Preventive Actions), and change controls associated with V&V activities.
* Contribute to regulatory submissions by preparing or reviewing technical documentation related to verification and validation