Life Sciences Manufacturing AI Transformation Manager

EY; Palo Alto (CA); Remote; USD 161,000 - 267,000; Full time

Benefits offered by this job

Medical and dental coverage

Pension and 401(k)

Paid time off options

Job summary

EY in the United States seeks a Manager to lead Life Sciences manufacturing transformation workstreams, turning plant-floor needs into actionable requirements and coordinating cross-functional teams across IT, engineering, and quality. The role focuses on technology-enabled delivery and regulated environments.

The position covers MES/MOM, ERP, LIMS, QMS integrations, data quality, and AI-driven insights, with significant travel to 80–100% as required and broad industry exposure in pharma,

Qualifications

• A bachelor's degree in engineering, life sciences, manufacturing, supply chain, information systems, business, or a related discipline.
• At least 7 years of relevant experience in Life Sciences manufacturing, manufacturing technology, operational excellence, industrial data and AI, technology consulting, or a related field.
• Experience leading a client-facing manufacturing, digital, data, or technology workstream through design and at least one implementation or deployment phase.
• Experience working in a pharmaceutical, biotechnology, medical-device, or comparably regulated manufacturing environment.
• Experience translating manufacturing needs into process, functional, data, integration, or testing deliverables and coordinating business and technical contributors.
• Practical understanding of GxP manufacturing and the documentation, change-control, quality, and data-integrity considerations relevant to digital solutions.
• Ability to travel as needed based on business and role requirements. Travel can range from 80-100%.

Responsibilities

• Lead client-facing workstreams in Life Sciences manufacturing transformation, with clear ownership of plans, deliverables, risks, decisions, and outcomes.
• Assess current-state production and quality processes, user needs, system landscapes, data flows, performance gaps, and site constraints through workshops, data analysis, and plant engagement.
• Translate priorities such as yield, throughput, right-first-time execution, batch-cycle time, deviation reduction, asset reliability, and supply continuity into process designs, requirements, acceptance criteria, and measurable improvements.
• Develop functional designs for relevant capabilities such as batch execution, electronic batch records, recipe management, genealogy, review by exception, connected-worker workflows, maintenance, and performance management.
• Coordinate integration requirements across MES/MOM, ERP, LIMS, QMS, historians, SCADA, DCS/PLC, asset-management systems, and cloud or edge platforms, working with architecture, automation, and cybersecurity specialists.
• Define and review data mappings, asset and batch context, master-data needs, interface specifications, and data-quality controls needed for reporting, analytics, and AI use cases.
• Help deliver analytics and AI use cases, such as process monitoring, predictive maintenance, deviation investigation support, and decision support, by assessing data readiness, workflow fit, evaluation criteria, and human oversight.
• Work with client quality and validation teams to reflect applicable GxP, data-integrity, electronic-record, change-control, and validation or risk-based assurance requirements in workstream deliverables.
• Oversee configuration activities and lead functional testing, defect resolution, deployment readiness, training, cutover support, hypercare, and handover for your workstream.
• Facilitate working sessions across manufacturing, quality, MS&T, engineering, supply chain, IT, OT, data, and technology-vendor teams; escape decisions and dependencies that affect the broader program.
• Manage workstream scope, schedule, resources, quality, and risks; provide clear status updates and contribute to estimates, proposals, and follow-on opportunity shaping.
• Coach junior team members, review their work products, and capture reusable requirements, design patterns, and delivery lessons.

Skills

Life Sciences manufacturing

Process design & requirements

Data analytics & AI in manufacturing

Workshop facilitation

Client stakeholder management

Delivery leadership

Education

Bachelor's degree in Engineering or Life Sciences

Tools

MES/MOM

ERP

LIMS

QMS

SCADA

DCS/PLC

Job description

EY in the United States seeks a Manager to lead Life Sciences manufacturing transformation workstreams, turning plant-floor needs into actionable requirements and coordinating cross-functional teams across IT, engineering, and quality. The role focuses on technology-enabled delivery and regulated environments.

The position covers MES/MOM, ERP, LIMS, QMS integrations, data quality, and AI-driven insights, with significant travel to 80–100% as required and broad industry exposure in pharma,