Life Sciences Manufacturing & AI Transformation Lead

EY; Charleston (WV); Remote; USD 128,000 - 257,000; Full time

Benefits offered by this job

Medical and dental coverage

Pension and 401(k)

Paid time off

Job summary

EY seeks a Life Sciences Manufacturing Manager to lead technology-enabled transformation workstreams that improve plant performance, quality, and supply reliability. You will coordinate cross-functional teams across MES/MOM, ERP, LIMS and other systems in regulated settings.

You will translate plant-floor needs into actionable requirements, own design and testing activities, and drive adoption, optimization, and value realization with senior leaders across manufacturing, quality, and IT.

Qualifications

• Bachelor's degree in engineering, life sciences, manufacturing, supply chain, information systems, business, or a related discipline.
• At least 7 years of relevant Life Sciences manufacturing or related experience.
• Experience leading a client-facing manufacturing, digital, data, or technology workstream.
• Experience in pharmaceutical/biotech/medical-device regulated environments.
• Experience translating manufacturing needs into process, functional, data, integration, or testing deliverables and coordinating contributors.
• GxP, data-integrity, electronic-record, change-control, and validation considerations for digital solutions.
• Ability to travel as needed, up to 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.
• Translate priorities into process designs, requirements, acceptance criteria, and measurable improvements.
• Develop functional designs for capabilities such as batch execution, electronic batch records, recipe management, genealogy, and connected-worker workflows.
• Coordinate integration requirements across MES/MOM, ERP, LIMS, QMS, historians, SCADA, DCS/PLC, and cloud/edge platforms.
• Define and review data mappings, master-data needs, interface specifications, and data-quality controls for reporting, analytics, and AI use cases.
• Help deliver analytics and AI use cases by assessing data readiness, workflow fit, evaluation criteria, and human oversight.
• Work with client quality and validation teams to reflect GxP, data-integrity, electronic-record, change-control and validation requirements in deliverables.
• Oversee configuration activities and lead functional testing, defect resolution, deployment readiness, training, cutover, hypercare, and handover.
• Facilitate working sessions across manufacturing, quality, MS&T, engineering, supply chain, IT, OT, data, and vendor teams; manage dependencies.
• Manage workstream scope, schedule, resources, quality, risks; contribute to estimates, proposals, and follow-on opportunities.
• Coach junior team members, review their work products, and capture reusable requirements and lessons.

Job description

EY seeks a Life Sciences Manufacturing Manager to lead technology-enabled transformation workstreams that improve plant performance, quality, and supply reliability. You will coordinate cross-functional teams across MES/MOM, ERP, LIMS and other systems in regulated settings.

You will translate plant-floor needs into actionable requirements, own design and testing activities, and drive adoption, optimization, and value realization with senior leaders across manufacturing, quality, and IT.