Are you an experienced, passionate pioneer in technology who wants to work in a collaborative environment? As an experienced Verification & Validation Test Lead 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.
Recruiting for this role ends on 9/11/2026
Work you’ll do/Responsibilities
The Verification & Validation Test Lead Senior Consultant will lead the Verification & Validation (V&V) activities for a Hayward, CA manufacturing site — an 8-application GMP portfolio (all High priority) including TrakSYS v3.1 (MES), EtQ Reliance v2020 (QMS), Genesis v2.0, MESA ViewPoint v1.4.3, MPort v3.2, ITS Data Warehouse, Subversion, and Acronis. The candidate must bring hands-on V&V lifecycle experience (IQ/OQ/PQ), 21 CFR Part 11 and GAMP 5 compliance knowledge, and the ability to lead site-based stakeholder communication in a cGMP drug-device manufacturing environment. Act as the onsite V&V testing representative at the Hayward CA site, building trusted relationships with site quality, engineering, and application owners. Execute V&V lifecycle activities (IQ/OQ/PQ) for validated manufacturing systems — MES (TrakSYS), QMS (EtQ Reliance), process control (Genesis), plant dashboards (MESA ViewPoint), and data integration (MPort). Author and execute V&V protocols, test scripts, and summary reports aligned to CSV/CSA methodology and risk-based testing framework. Ensure all V&V documentation meets 21 CFR Part 11, cGMP, and GAMP 5 standards including electronic records, audit trail verification, and data integrity (ALCOA++) compliance. Lead UAT and qualification coordination — organizing sessions, aligning business testers and quality reviewers, and driving sign-off. Manage defect and deviation lifecycle with clear stakeholder communication on status, severity triage, and closure timelines. Support CAPA, change control, and periodic review activities for validated manufacturing systems. Deliver regular V&V status reports and qualification readiness updates to Hayward site stakeholders and central Testing Shared Services team. The successful candidate would possess these skills:
- 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
- 5+ years of executing V&V lifecycle activities (IQ/OQ/PQ) for validated manufacturing systems — MES (TrakSYS), QMS (EtQ Reliance), process control (Genesis), plant dashboards (MESA ViewPoint), and data integration (MPort).
- Author and execute V&V protocols, test scripts, and summary reports aligned to CSV/CSA methodology and risk-based testing framework.
- Ensure all V&V documentation meets 21 CFR Part 11, cGMP, and GAMP 5 standards including electronic records, audit trail verification, and data integrity (ALCOA++) compliance.
- Manage defect and deviation lifecycle with clear stakeholder communication on status, severity triage, and closure timelines.
- Support 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 $120,200 - $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.