V&V Test Coordinator - AI & Engineering Job Princeton area,New Jersey USA,Quality Assurance

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.

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 work streams

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.
Ability to lead site-based stakeholder communication with project managers, quality, engineering, and application owners.
Experience leading UAT/qualification coordination, defect and deviation lifecycle management.
Experience preparing V&V status reports and release/qualification readiness updates.
Experience supporting CAPA, change control, and periodic review activities for validated manufacturing systems.

Bachelor’s degree, preferably in information technology, business, or healthcare related field; or equivalent experience

Limited immigration sponsorship may be available

Ability to travel 10%, on average, based on the work you do and the clients and industries/sectors you serve

The wage range for this role takes into account the wide range of factors that are considered in making compensation decisions including but not limited to skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled.

At Deloitte, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current…