AI Enabled CSV Analyst

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:
Quality

Job Sub Function:
Digital Quality

Job Category:
Professional

All Job Posting Locations:
Raritan, New Jersey, United States of America

Job Description:

The Digital Enablement Lead supports the Digital transformation within the Technology Quality (TQ) team. This role drives AI-enabled process improvements, intelligent automation, and data driven decision support across Computer Systems Validation (CSV) processes.

The Digital Enablement Lead identifies and validates high-impact use cases, partners with stakeholders to translate business problems into solutions, build prototypes, and lead adoption through effective partnership, training, and governance. This position combines AI/ML software development lifecycle expertise and CSV experience with a strong ability to translate strategy into scalable solutions.

• Designs and implements practical AI-driven user cases partnering with stakeholders to translate business problems into measurable, implementable AI use cases.
• Runs feasibility and impact analyses, build prototypes, and drive adoption through effective stakeholder enablement.
• Ensures the quality of AI-generated outputs, agent behaviors, and AI-assisted workflows by building benchmark scenarios, defining scoring rubrics, evaluating business usefulness, and identifying failure patterns.
• Owns end-to-end governance, validation, and lifecycle oversight of AI agents used across CSV processes, ensuring they remain fit for intended use, compliant, controlled, and auditable throughout deployment and operation.
• Partners with Technology Quality leaders and SMEs to define the AI roadmap, maintaining a prioritized use-case catalog, and aligning initiatives to business goals.
• Translates business needs into structured use cases with objectives, success metrics, data requirements, risks, controls, and proposed models/techniques.
• Maintains an AI/Agent Inventory including control over Intended Use.
• Creates lightweight prototypes (scripts, dashboards, prompt experiments) to validate solution hypotheses and value case.
• Design and implement AI solutions for CSV processes enabling decision support, and workflow automation.
• Collaborate with data Science, engineering, and other technology teams to define data pipelines, model evaluation criteria, acceptance tests, and integration requirements.
• Translate business processes into product requirements, user stories, and acceptance criteria for data scientists, ML engineers, and product teams.
• Compare performance across prompt versions, workflow revisions, tools, and models; surface evidence for release decisions and regression/improvement.
• Establish benchmark scenarios and scoring rubrics to evaluate AI outputs, agent behaviors, and workflows in real business contexts.
• Assess outputs for groundedness, instruction adherence, consistency, usefulness, tone, control compliance, and risk; identify hallucinations, unsupported assertions, missing logic, and unsafe recommendations.
• Prepare test scripts, coordinate UAT, document outcomes, and support validation and release documentation.
• Define prompt design strategies, guardrails, and explainability requirements; implement human-in-the-loop controls and risk mitigation strategies.
• Ensure all AI use cases align with J&J Responsible AI ,GenAI and Q&C usage guidelines
• Partner with SMEs to monitor ethical, privacy, and regulatory considerations for each use case (e.g., 21 CFR Part 11, GxP, Annex)

Required Knowledge, Skills and Abilities (Uncompromised requirements for the role):

• Bachelor's or master's degree in business, Data Science, Statistics, Computer Science, or related field; or equivalent practical experience.
• 2+ years in roles such as business analyst, data analyst, quality analyst, QMS analyst, or CSV lead.
• 5+ years of professional experience with software development or software delivery lifecycles.
• Proven track record deploying LLMs, AI agents, or GenAI-powered applications in production and integrating GenAI into business workflows for measurable impact.
• Strong understanding of prompt engineering, model evaluation, and techniques for tuning/adaptation; familiarity with RAG and orchestration of agentic workflows.
• Data literacy: analyze datasets, build reports, visualize metrics; disciplined approach to data quality and lineage.
• Business analysis skills: requirements gathering, process mapping, writing clear specifications, and supporting testing and validation.
• Effective communication, critical thinking, pattern recognition, creative problem solving, and process orientation.
• Experience evaluating outputs against nuanced criteria (beyond binary correctness) and making risk-informed decisions.
• Compliance awareness: operating in regulated environments and adherence to procedures (e.g., GxP, Part 11, Annex 11).
• Experience authoring Software development documentation, non-conformities, Change Requests, SOPs, Validation Plans and Reports

Required Skills:

Preferred Skills:
Coaching, Communication, Compliance Management, Continuous Improvement, Controls Compliance, Digital Assurance, Econometric Models, Issue Escalation, Performance Measurement, Problem Solving, Process Optimization, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Compliance, Standard Operating Procedure (SOP), Technologically Savvy

The anticipated base pay range for this position is :
$94,000.00 - $151,800.00

Additional Description for Pay Transparency:
This position is eligible to participate in the Company's long-term incentive program.

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

Vacation -120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year

Holiday pay, including Floating Holidays -13 days per calendar year

Work, Personal and Family Time - up to 40 hours per calendar year

Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child

Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

Caregiver Leave - 80 hours in a 52-week rolling period10 days

Volunteer Leave - 32 hours per calendar year

Military Spouse Time-Off - 80 hours per calendar year

For additional general information on Company benefits, please go to: -