Life Sciences Manufacturing AI Transformation Lead

EY; Alpharetta (GA); Remote; USD 128,000 - 257,000; Full time

Benefits offered by this job

Medical and dental coverage

Pension

401(k) plans

Paid time off

Job summary

EY in the United States seeks a Client-facing Life Sciences Manufacturing Manager to lead technology-enabled transformation projects across plant operations. You will drive delivery from assessment through implementation, coordinating MES/MOM, ERP, LIMS, QMS, and OT/IT interfaces in regulated environments.

The role emphasizes turning plant-floor needs into functional designs, analytics use cases, and effective data management, with strong stakeholder facilitation.

Qualifications

• Bachelor's degree in engineering, life sciences, manufacturing, supply chain, information systems, business or related discipline.
• At least 7 years of relevant experience in Life Sciences manufacturing, manufacturing technology, operational excellence, industrial data and AI, technology consulting, or 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; travel can range from 80-100%.

Responsibilities

• Lead client-facing workstreams in Life Sciences manufacturing transformation with 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 and data analysis.
• Translate priorities into process designs, requirements, acceptance criteria, and measurable improvements.
• Develop functional designs for batch execution, electronic batch records, and related capabilities.
• Coordinate integration requirements across MES/MOM, ERP, LIMS, QMS, historians, and OT/IT systems with architecture and cybersecurity teams.
• Define data mappings, master-data needs, interface specs, and data-quality controls for reporting, analytics, and AI use cases.
• Support analytics and AI use cases by assessing data readiness, workflow fit, evaluation criteria, and human oversight.
• Work with quality and validation teams to reflect GxP, data integrity, change-control, and validation requirements in deliverables.
• Oversee configuration activities, testing, deployment readiness, training, cutover, hypercare, and handover for the workstream.
• Facilitate sessions across manufacturing, quality, IT, OT, and vendor teams to resolve cross-program dependencies.
• Manage scope, schedule, resources, quality, risks; contribute to estimates, proposals, and follow-on opportunities.
• Coach junior team members and capture reusable requirements and lessons learned.

Skills

Manufacturing in Life Sciences

Workflow mapping

IT/OT data flows

Batch/Equipment data

Analytics & AI judgment

Workshop facilitation

Education

Bachelor's degree in engineering, life sciences, manufacturing, supply chain, information systems, or business

Tools

MES/MOM

Electronic batch records

Recipe management

APIs & historians

Job description

EY in the United States seeks a Client-facing Life Sciences Manufacturing Manager to lead technology-enabled transformation projects across plant operations. You will drive delivery from assessment through implementation, coordinating MES/MOM, ERP, LIMS, QMS, and OT/IT interfaces in regulated environments.

The role emphasizes turning plant-floor needs into functional designs, analytics use cases, and effective data management, with strong stakeholder facilitation.