Life Sciences Manufacturing Transformation Lead

EY; Cincinnati (OH); Vor Ort; USD 128.000 - 267.000; Vollzeit

Zusammenfassung

EY is seeking a Life Sciences Manufacturing Manager to lead technology-enabled transformation across pharma, biotech and medical-device clients. You will drive end-to-end workstreams from assessment through design, implementation, testing, adoption and stabilization in regulated environments.

The role combines practical plant-floor knowledge with digital, data and AI delivery, coordinating cross-functional teams and ensuring quality and compliance while delivering measurable improvements in

Qualifikationen

• Bachelor's degree in engineering, life sciences, manufacturing, supply chain, information systems, or related discipline.
• At least 7 years of relevant Life Sciences manufacturing, manufacturing technology, operational excellence, industrial data and AI, technology consulting, or 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%.

Aufgaben

• 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 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.

Kenntnisse

Life Sciences manufacturing

Digital & AI

Program management

Client-facing

Data analysis

GxP knowledge

Ausbildung

Bachelor's degree in engineering or life sciences

Tools

MES/MOM

ERP

LIMS

QMS

SCADA

DCS/PLC

cloud/edge platforms

Jobbeschreibung

EY is seeking a Life Sciences Manufacturing Manager to lead technology-enabled transformation across pharma, biotech and medical-device clients. You will drive end-to-end workstreams from assessment through design, implementation, testing, adoption and stabilization in regulated environments.

The role combines practical plant-floor knowledge with digital, data and AI delivery, coordinating cross-functional teams and ensuring quality and compliance while delivering measurable improvements in