Life Sciences Manufacturing AI Transformation Leader

EY

Greenville (SC)

Hybrid

USD 128,000 - 235,000

Full time

3 days ago
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Benefits offered by this job

Medical and dental coverage
401(k) plan

Job summary

EY is seeking a Client-facing Life Sciences Manufacturing Manager to lead technology-enabled transformation workstreams across regulated environments. You will drive design, implementation, testing, and stabilization for manufacturing, quality, and supply continuity initiatives in pharmaceutical, biotech, and medical-device settings.

This techno-functional role combines practical plant-floor know‑how with digital, data, AI, and delivery skills, coordinating cross-functional teams and ensuring

Qualifications

  • A bachelor's degree in engineering, life sciences, manufacturing, information systems, business, or a related discipline.
  • At least 7 years of relevant experience in Life Sciences manufacturing, manufacturing technology, operational excellence, industrial data and AI, technology consulting, or a related field.
  • Experience leading a client-facing manufacturing, digital, data, or technology workstream through design and at least one implementation or deployment phase.
  • Experience working in a pharmaceutical, biotechnology, medical-device, or comparably regulated manufacturing environment.
  • Experience translating manufacturing needs into process, functional, data, integration, or testing deliverables and coordinating business and technical contributors.
  • Practical understanding of GxP manufacturing and the documentation, change-control, quality, and data-integrity considerations relevant to digital solutions.
  • Ability to travel as needed based on business and role requirements. Travel can range from 80-100%.

Responsibilities

  • Lead client-facing workstreams in Life Sciences manufacturing transformation, with clear 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 through workshops, data analysis, and plant engagement.
  • Translate priorities such as yield, throughput, right-first-time execution, batch-cycle time, deviation reduction, asset reliability, and supply continuity into process designs, requirements, acceptance criteria, and measurable improvements.
  • Develop functional designs for relevant capabilities such as batch execution, electronic batch records, recipe management, genealogy, review by exception, connected-worker workflows, maintenance, and performance management.
  • Coordinate integration requirements across MES/MOM, ERP, LIMS, QMS, historians, SCADA, DCS/PLC, asset-management systems, and cloud or edge platforms, working with architecture, automation, and cybersecurity specialists.
  • Define and review data mappings, asset and batch context, master-data needs, interface specifications, and data-quality controls needed for reporting, analytics, and AI use cases.
  • Help deliver analytics and AI use cases, such as process monitoring, predictive maintenance, deviation investigation support, and decision support, by assessing data readiness, workflow fit, evaluation criteria, and human oversight.
  • Work with client quality and validation teams to reflect applicable GxP, data-integrity, electronic-record, change-control, and validation or risk-based assurance requirements in workstream deliverables.
  • Oversee configuration activities and lead functional testing, defect resolution, deployment readiness, training, cutover support, hypercare, and handover for your workstream.
  • Facilitate working sessions across manufacturing, quality, MS&T, engineering, supply chain, IT, OT, data, and technology-vendor teams; escape decisions and dependencies that affect the broader program.
  • Manage workstream scope, schedule, resources, quality, and risks; provide clear status updates and contribute to estimates, proposals, and follow-on opportunity shaping.
  • Coach junior team members, review their work products, and capture reusable requirements, design patterns, and delivery lessons.

Skills

Life Sciences manufacturing
Data analytics
Delivery leadership
Client-facing delivery
Workshop facilitation

Education

Bachelor's degree in engineering or life sciences

Tools

MES/MOM
ERP systems
LIMS
QMS
SCADA/DCS

Job description

EY is seeking a Client-facing Life Sciences Manufacturing Manager to lead technology-enabled transformation workstreams across regulated environments. You will drive design, implementation, testing, and stabilization for manufacturing, quality, and supply continuity initiatives in pharmaceutical, biotech, and medical-device settings.

This techno-functional role combines practical plant-floor know‑how with digital, data, AI, and delivery skills, coordinating cross-functional teams and ensuring

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