V&V Test Coordinator - AI & Engineering

Are you an experienced, passionate pioneer in technology who wants to work in a collaborative environment? As an experienced V&V Test Coordinator Senior Consultant, you will have the ability to share new ideas and collaborate on projects as a consultant without the extensive demands of travel.

If so, consider an opportunity with Deloitte under our Project Talent Model.

Project Talent Model (PTM) is a talent model that is tailored specifically for long-term, onsite client service delivery.

Work you'll do/Responsibilities


* Senior Consultant to own Verification & Validation (V&V) activities for Otsuka's Hayward manufacturing site, acting as the onsite V&V testing representative.



* Executes V&V lifecycle activities (IQ/OQ/PQ) for validated systems including TrakSYS (MES), Genesis, MESA Viewpoint, MPort, and related manufacturing/laboratory applications.



* Authors and executes V&V protocols, test scripts, and summary reports aligned to GxP/CSV/CSA methodology and Otsuka's risk-based testing framework.



* Leads UAT and qualification coordination, manages defect/deviation lifecycle, and delivers V&V status and release/qualification readiness updates to site stakeholders and the central Testing Shared Services team.



* Ability to work independently and collaborate as part of a team



* Effective written and verbal communication skills


* Meticulous attention to detail and quality of work product


* Ability to build and sustain professional relationships


* Ability to lead projects or workstreams


* Ability to manage and prioritize multiple tasks in a fast-paced and dynamic environment


* Strong interpersonal skills and professional demeanor


* Ability to meet deadlines


* Ability to provide clear guidance to others

The Team

AI & Engineering leverages cutting-edge engineering capabilities to build, deploy, and operate integrated/verticalized sector solutions in software, data, AI, network, and hybrid cloud infrastructure.

These solutions are powered by engineering for business advantage, transforming mission-critical operations.

We enable clients to stay ahead with the latest advancements by transforming engineering teams and modernizing technology & data platforms.

Our delivery models are tailored to meet each client's unique requirements

Our Industry Solutions offering provides verticalized solutions that transform how clients sell products, deliver services, generate growth, and execute mission-critical operations.

We deliver integrated business expertise with scalable, repeatable technology solutions specifically engineered for each sector.

Qualifications Required


* % years + Hands-on V&V lifecycle experience (IQ/OQ/PQ) in a cGMP drug-device manufacturing environment.
• 21 CFR Part 11 and GAMP 5 compliance knowledge; data integrity (ALCOA++) experience.
• Experience performing Functional Risk Assessments (FRA) and maintaining requirement traceability matrices.
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