Life Sciences Manufacturing Transformation Lead (AI)

EY; Denver (CO); Remote; USD 128,000 - 267,000; Full time

Benefits offered by this job

Medical and dental coverage

Pension and 401(k) plans

Paid time off

Job summary

EY is seeking a Manager in Life Sciences manufacturing to lead technology-enabled transformation workstreams across regulated environments. You will coordinate client teams, translate plant-floor needs into actionable requirements, and drive joint delivery with functional and technical specialists.

The role emphasizes GxP, data readiness, and validation considerations. EY offers a comprehensive rewards package and opportunities to work across pharmaceutical, biotech, and medical-device clients.

Qualifications

• Bachelor’s degree in engineering, life sciences, manufacturing, or related field.
• At least 7 years of Life Sciences manufacturing and related experience.
• Experience leading client-facing manufacturing or digital workstreams through design and deployment.
• Experience in regulated pharmaceutical/biotech/medical-device environments.
• Ability to translate manufacturing needs into actionable deliverables and tests.

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 like yield, throughput, right-first-time execution, batch-cycle time into designs, requirements, and criteria.
• Develop functional designs for batch execution, electronic batch records, recipe management, genealogy, and related capabilities.
• 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 specs, and data-quality controls for reporting, analytics, and AI use cases.
• Support analytics and AI use cases by assessing data readiness, workflow fit, evaluation criteria, and human oversight.
• Work with quality and validation teams to reflect GxP, data-integrity, electronic-record, change-control, and validation requirements.
• Oversee configuration activities and lead testing, defect resolution, deployment readiness, training, cutover, and handover.
• Facilitate working sessions across manufacturing, quality, IT, engineering, supply chain, data, and vendors.
• Manage workstream scope, schedule, resources, quality, and risks; provide status updates and contribute to estimates and proposals.
• Coach junior team members and capture reusable requirements and delivery lessons.

Job description

EY is seeking a Manager in Life Sciences manufacturing to lead technology-enabled transformation workstreams across regulated environments. You will coordinate client teams, translate plant-floor needs into actionable requirements, and drive joint delivery with functional and technical specialists.

The role emphasizes GxP, data readiness, and validation considerations. EY offers a comprehensive rewards package and opportunities to work across pharmaceutical, biotech, and medical-device clients.