Life Sciences Manufacturing & AI Transformation Lead

EY

San Francisco (CA)

Remoto

USD 161.000 - 267.000

Tempo pieno

3 giorni fa

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Descrizione del lavoro

EY is seeking a Life Sciences Manufacturing Manager to lead technology-enabled transformation across regulated environments, delivering improvements in plant performance, quality, and supply reliability. You will guide workstreams from requirements through design, implementation, testing, and stabilization, partnering with architecture, automation, and cybersecurity teams.

This techno-functional role requires strong workshop facilitation, client leadership, and the ability to translate

Competenze

Bachelor's degree in engineering, life sciences, manufacturing, supply chain, information systems, business or related discipline.
7+ years of relevant Life Sciences manufacturing, manufacturing technology, operational excellence, industrial data and AI, technology consulting, or related field.
Experience leading client-facing manufacturing/digital/data/technology workstreams through design and at least one implementation or deployment phase.
Experience in pharmaceutical, biotechnology, medical-device, or comparably regulated manufacturing environments.
Ability to translate manufacturing needs into process, functional, data, integration, or testing deliverables; coordinate business and technical contributors.
Knowledge of GxP, data integrity, electronic records, change-control, validation requirements for digital solutions.
Ability to travel 80-100% as needed.

Mansioni

Lead client-facing workstreams in Life Sciences manufacturing transformation with accountability for plans, deliverables, risks, decisions, and outcomes.
Assess current-state production and quality processes, user needs, data flows, 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, 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 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, and human oversight.
Ensure compliance with validation and data integrity in collaboration with quality teams.
Oversee configuration activities, testing, deployment readiness, training, cutover, and handover.
Facilitate cross-functional sessions with manufacturing, quality, IT, OT, data, and vendors to manage risks and dependencies.