Senior Life Sciences Manufacturing & AI Transformation Lead

EY; Raleigh (NC); Remote; USD 97,000 - 178,000; Full time

Job summary

EY in the United States seeks a Senior in Supply Chain Manufacturing to design, build, test, and deploy digital solutions for regulated plant operations across pharma, biotech, and medical-device clients.

You will engage with operators, engineers, quality teams, IT and OT, own deliverables, and translate shop-floor workflows into testable requirements, while guiding integration and validation activities across the program.

Qualifications

• Bachelor’s degree in engineering, life sciences, manufacturing, information systems, computer science, supply chain, or related discipline.
• 3+ years of Life Sciences manufacturing, manufacturing systems, automation, or related field.
• Experience with regulated environments (pharma/biotech/medical devices).
• Experience producing requirements, process maps, data mappings, interface specs, or deployment materials.
• Experience collaborating with operational and technical teams to investigate requirements and resolve issues.

Responsibilities

• Assess workflows, user needs, interfaces, data points, and pain points through observations and data review.
• Document process flows, user stories, functional requirements, data mappings, and acceptance criteria for digital manufacturing solutions.
• Support design and implementation of MES/ERP-related capabilities and eDHRs, batch management, and plant performance reporting.
• Trace data across MES/MOM, ERP, LIMS, QMS, historians, SCADA, DCS/PLC, and asset-management platforms; identify data gaps and integration dependencies.
• Develop equipment and batch hierarchies, data-quality rules, and contextualized datasets with manufacturing and data teams.
• Interface with solution architects on interface specs, APIs, and industrial connectivity for plant-to-enterprise data movement.
• Configure or prototype solution components and document design decisions for review by leaders.
• Prepare and execute functional and integration test scripts, manage defects, and maintain traceability between requirements and tests.
• Support deployment readiness, cutover, user training, hyper-care, and handover with technical documentation.
• Collaborate with client quality and validation teams on GxP, data integrity, electronic records, change control, and computer system validation.
• Contribute to analytics and AI use cases by assessing data quality and manufacturing context, and documenting when human review is needed.
• Communicate progress, risks, dependencies, and next steps to client counterparts and leads; coordinate tasks with junior colleagues.

Skills

Manufacturing knowledge

Data integration

Delivery discipline

Technical communication

Regulated-delivery

Analytical judgment

Education

Bachelor’s degree in engineering or life sciences

Tools

MES/MOM

eDHRs

LIMS

QMS

ISA-88/61512 concepts

ISA-95/62264 models

OPC UA / MQTT

Job description

EY in the United States seeks a Senior in Supply Chain Manufacturing to design, build, test, and deploy digital solutions for regulated plant operations across pharma, biotech, and medical-device clients.

You will engage with operators, engineers, quality teams, IT and OT, own deliverables, and translate shop-floor workflows into testable requirements, while guiding integration and validation activities across the program.