V&V Test Coordinator - AI & Engineering

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 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.

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.

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 range is $107,200 - $145,000.

You may also be eligible to participate in a discretionary annual incentive program, subject to the rules governing the program, whereby an award, if any, depends on various factors, including, without limitation, individual and organizational performance.

Deloitte is committed to providing reasonable accommodations for people with disabilities. If you require a reasonable accommodation to participate in the recruiting process, please direct your inquiries to the Global Call Center (GCC) at

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Deloitte's purpose is to make an impact that matters for our people, clients, and communities. At Deloitte, purpose is synonymous with how we work every day. It defines who we are. Our purpose comes through in our work with clients that enables impact and value in their organizations, as well as through our own investments, commitments, and actions across areas that help drive positive…