Senior Life Sciences Manufacturing & AI Transformation Lead

EY

New Brunswick (NJ)

Remote

USD 97,000 - 178,000

Full time

4 days ago

Be an early applicant

A complete application in a minute

Tailored resume and cover letter, ready to send.

Get past ATS filters

Benefits offered by this job

Medical and dental coverage

401(k) and retirement plans

Paid time off

Job summary

EY is seeking 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 connect production, quality, laboratory, and IT teams with deployable technology, contributing throughout the delivery lifecycle from assessments to deployment and stabilization.

You will own technical deliverables, resolve issues, and translate shop-floor insights into requirements, testable designs,

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, or related field.
Experience working in pharma/biotech/medical-device or other regulated environments.

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 the design and implementation of capabilities such as manufacturing execution, electronic batch records and electronic device history records (eDHRs), recipe and routing management, batch and unit genealogy, review by exception, connected-worker workflows, and plant performance reporting.
Trace information across relevant systems (MES/MOM, ERP, LIMS, QMS, historians, SCADA, DCS/PLC) and 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 and engineers on interface specifications, APIs, and industrial connectivity between plant, edge, and enterprise environments.
Prepare and execute functional and integration test scripts, record defects, 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 to review documentation concerning 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 documenting where human review is needed.
Communicate progress, risks, and next steps to client counterparts and engagement leaders; coordinate tasks with junior colleagues.