V&V Test Coordinator - AI & Engineering

Relha LLC; Princeton (NJ); On-site; USD 107,000 - 145,000; Full time

Job summary

Deloitte is seeking an experienced V&V Test Coordinator Senior Consultant to own Verification & Validation activities for our clients, including IQ/OQ/PQ execution for validated systems such as MES and related applications. You will author protocols, test scripts, and summary reports within a cGMP/CSV framework and coordinate UAT across site stakeholders.

You will lead cross-functional collaboration, manage defect lifecycle, and provide status updates to the central Testing Shared Services team,

Qualifications

• 21 CFR Part 11 and GAMP 5 compliance knowledge; data integrity (ALCOA++) experience.
• 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.

Responsibilities

• Own Verification & Validation activities for on-site manufacturing systems.
• Authors and executes V&V protocols, test scripts, and summary reports aligned to GxP/CSV framework.
• Leads UAT and qualification coordination, manages defect/deviation lifecycle.
• Delivers V&V status and release readiness updates to site stakeholders and Testing Shared Services.

Skills

V&V experience

IQ/OQ/PQ

21 CFR Part 11

GAMP 5

FRA

data integrity ALCOA++

UAT coordination

qualification management

CAPA and change control

stakeholder communication

Education

Bachelor's degree in IT/Business/Healthcare

Tools

TrakSYS

Genesis

MESA Viewpoint

MPort

Job description

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 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.
• 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 [e-mail].

Recruiting tips

From developing a stand out resume to putting your best foot forward in the interview, we want you to feel prepared and confident as you explore opportunities at Deloitte. Check out recruiting tips from Deloitte recruiters.

At Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits. Learn more about what working at Deloitte can mean for you.

Our people and culture

Our inclusive culture empowers our people to be who they are, contribute their unique perspectives, and make a difference individually and collectively. It enables us to leverage different ways of thinking, ideas, and perspectives, and bring more creativity and innovation to help solve our clients' most complex challenges. This makes Deloitte one of the most rewarding places to work.

Our purpose

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 outcomes for our communities. Learn more.

From entry-level employees to senior leaders, we believe there’s always room to learn. We offer opportunities to build new skills, take on leadership opportunities and connect and grow through mentorship. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career.

As used in this posting, "Deloitte" means Deloitte Consulting LLP, a subsidiary of Deloitte LLP. Please see https://www.deloitte.com/us/about for a detailed description of the legal structure of Deloitte LLP and its subsidiaries.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or protected veteran status, or any other legally protected basis, in accordance with applicable law.

For individuals assigned and/or hired to work in {insert location}, Deloitte is required by law to include a reasonable estimate of the compensation range for this role. This compensation range is specific to {insert location} and 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. 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$107000 to $143000.

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 [e-mail].

Recruiting tips

From developing a stand out resume to putting your best foot forward in the interview, we want you to feel prepared and confident as you explore opportunities at Deloitte. Check out recruiting tips from Deloitte recruiters.

At Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits. Learn more about what working at Deloitte can mean for you.

Our people and culture

Our inclusive culture empowers our people to be who they are, contribute their unique perspectives, and make a difference individually and collectively. It enables us to leverage different ways of thinking, ideas, and perspectives, and bring more creativity and innovation to help solve our clients' most complex challenges. This makes Deloitte one of the most rewarding places to work.

Our purpose

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 outcomes for our communities. Learn more.

From entry-level employees to senior leaders, we believe there’s always room to learn. We offer opportunities to build new skills, take on leadership opportunities and connect and grow through mentorship. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career.

As used in this posting, ""Deloitte"" means Deloitte Consulting LLP, a subsidiary of Deloitte LLP. Please see https://www.deloitte.com/us/about for a detailed description of the legal structure of Deloitte LLP and its subsidiaries.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or protected veteran status, or any other legally protected basis, in accordance with applicable law.