Senior Life Sciences Manufacturing Ops & AI Transformation

EY

Woodbridge Township (NJ)

Remote

USD 97,000 - 178,000

Full time

5 days ago

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Job summary

EY seeks a Senior in Supply Chain Manufacturing to design, build, test, and deploy digital solutions for regulated plant operations in the Life Sciences space. You will connect production, quality, lab, and IT to deliver fit-for-purpose workflows and data-driven decisions across MES/MOM, LIMS, and QMS ecosystems.

You will collaborate with operators, engineers, and validation teams, owning deliverables from requirements to deployment and handover, while ensuring GxP compliance and robust data

Qualifications

Bachelor’s degree in engineering, life sciences, manufacturing, information systems, computer science, supply chain, or related discipline.
At least 3 years of relevant experience in Life Sciences manufacturing, manufacturing systems, automation, industrial data, systems implementation, technology consulting, or related field.
Experience with pharmaceutical/biotech/medical-device or regulated environments.
Experience producing technical or functional delivery artifacts (requirements, process maps, data mappings, interface specs, configuration docs, test scripts).
Experience collaborating with operations and technical delivery teams.
Ability to travel as needed; travel can range from 80-100%.

Responsibilities

Assess manufacturing and quality workflows, user needs, system interfaces, equipment data, and current-state pain points through site observations, interviews, workshops, and data review.
Document process flows, user stories, functional requirements, data mappings, interface requirements, controls, and acceptance criteria for digital manufacturing solutions.
Support design and implementation of capabilities such as MES/MOM, eBRs/eDHRs, recipe and routing management, batch genealogy, and plant performance reporting.
Trace information across MES/MOM, ERP, LIMS, QMS, historians, SCADA, DCS/PLC, and asset-management platforms; identify data gaps and integration dependencies.
Develop and review equipment and batch hierarchies, source-to-target mappings, data-quality rules, and contextualized datasets with manufacturing, automation, and data specialists.
Work with solution architects on interface specs, APIs, industrial connectivity, and data movement between plant, edge, and enterprise environments.
Configure or prototype solution components and document design decisions for review by technical/client leads.
Prepare and execute functional and integration test scripts, record defects, support resolution and retesting, and maintain traceability between requirements and test evidence.
Support deployment readiness, cutover, user training, hyper-care, and handover with clear technical documentation.
Partner with client quality and validation teams on GxP, data integrity, electronic records, change control, and computer system validation or risk-based assurance.
Contribute to analytics and AI use cases by assessing source-data quality and manufacturing context.
Communicate progress, risks, dependencies, and next steps to client counterparts and engagement leaders; coordinate tasks with junior colleagues.

Skills

Manufacturing & Quality

Manufacturing technology

Data & Integration

Delivery discipline

Technical communication

Regulated-delivery awareness

Analytical judgment

Education

Bachelor's degree in engineering/ Life sciences/ manufacturing/ information systems

Tools

MES/MOM

LIMS

QMS

SCADA

DCS/PLC

OPC UA

MQTT/Sparkplug

Electronic batch records/eDHRs

Job description

You will collaborate with operators, engineers, and validation teams, owning deliverables from requirements to deployment and handover, while ensuring GxP compliance and robust data

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